BRANMOOR
THURSDAY · 14 MAY 2026
Branmoor

Device Failure Surveillance

A live, classified register of FDA medical-device recalls and field corrections — implants, surgical mesh, orthopedic hardware, cardiac rhythm devices, infusion pumps, ventilators, anesthesia equipment, and more. Sourced directly from the openFDA Device Enforcement Reports API. Each recall carries the FDA Class designation, the recalling manufacturer, the distribution scope, and the operational severity framing hospital value analysis committees and plaintiff firms need to triage response. See the methodology for sourcing and how Branmoor computes severity.

2204Class I (life-threatening)
22137Class II
16255Recently terminated

Displaying the top 3000 most-actionable device recalls (Class I and ongoing first, then by recency). All 25000 historical recalls from the openFDA dataset are available via the CSV exports above.

Recall # Device Manufacturer Class Status
Z-1801-2026 B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Initiated 2026-03-19
B Braun Medical Inc
Bethlehem, PA
Class I Ongoing
Z-1797-2026 Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Initiated 2026-03-12
Insulet Corporation
Acton, MA
Class I Ongoing
Z-1617-2026 Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Initiated 2026-03-02
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1616-2026 Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Initiated 2026-03-02
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1615-2026 Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Initiated 2026-03-02
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1647-2026 Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Initiated 2026-03-02
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1649-2026 Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Initiated 2026-03-02
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1719-2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1713-2026 NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; …
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1716-2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1714-2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1720-2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1728-2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1712-2026 NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10M…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1718-2026 NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1723-2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1722-2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1715-2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1588-2026 Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Initiated 2026-02-18
Navajo Manufacturing Company
Denver, CO
Class I Ongoing
Z-1575-2026 CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K…
Initiated 2026-02-13
Merit Medical Systems, Inc.
South Jordan, UT
Class I Ongoing
Z-1576-2026 ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, …
Initiated 2026-02-13
Merit Medical Systems, Inc.
South Jordan, UT
Class I Ongoing
Z-1577-2026 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Initiated 2026-02-13
Merit Medical Systems, Inc.
South Jordan, UT
Class I Ongoing
Z-1579-2026 BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96…
Initiated 2026-02-13
Merit Medical Systems, Inc.
South Jordan, UT
Class I Ongoing
Z-1566-2026 Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
Initiated 2026-02-12
Erbe USA Inc
Marietta, GA
Class I Ongoing
Z-1568-2026 Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Initiated 2026-02-12
Erbe USA Inc
Marietta, GA
Class I Ongoing
Z-1546-2026 Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descripti…
Initiated 2026-02-06
Trividia Health, Inc.
Fort Lauderdale, FL
Class I Ongoing
Z-1547-2026 Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description…
Initiated 2026-02-06
Trividia Health, Inc.
Fort Lauderdale, FL
Class I Ongoing
Z-1548-2026 Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description…
Initiated 2026-02-06
Trividia Health, Inc.
Fort Lauderdale, FL
Class I Ongoing
Z-1470-2026 Impella RP Flex with SmartAssist. Product Code: 1000323.
Initiated 2026-01-27
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-1469-2026 Impella RP with SmartAssist. Product Code: 0046-0035.
Initiated 2026-01-27
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-1471-2026 Impella RP. Product Code: 0046-0011.
Initiated 2026-01-27
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-1354-2026 Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automat…
Initiated 2026-01-16
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-1353-2026 Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa…
Initiated 2026-01-16
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-1320-2026 Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-…
Initiated 2025-12-22
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1319-2026 Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ St…
Initiated 2025-12-22
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1325-2026 Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Syste…
Initiated 2025-12-22
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1322-2026 Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic…
Initiated 2025-12-22
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1161-2026 HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Initiated 2025-12-19
Boston Scientific Corporation
Marlborough, MA
Class I Ongoing
Z-1158-2026 AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Initiated 2025-12-19
Boston Scientific Corporation
Marlborough, MA
Class I Ongoing
Z-1163-2026 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Initiated 2025-12-19
Boston Scientific Corporation
Marlborough, MA
Class I Ongoing
Z-1159-2026 AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Initiated 2025-12-19
Boston Scientific Corporation
Marlborough, MA
Class I Ongoing
Z-1115-2026 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve…
Initiated 2025-12-15
SunMed Holdings, LLC
Grand Rapids, MI
Class I Ongoing
Z-0933-2026 Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Initiated 2025-11-24
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-0913-2026 GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; …
Initiated 2025-11-14
GE Medical Systems China Co., Ltd. Class I Ongoing
Z-1001-2026 Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Initiated 2025-11-11
AVID Medical, Inc.
Toano, VA
Class I Ongoing
Z-1000-2026 Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Initiated 2025-11-11
AVID Medical, Inc.
Toano, VA
Class I Ongoing
Z-0586-2026 IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).…
Initiated 2025-11-03
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-0430-2026 BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100,…
Initiated 2025-10-17
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-0444-2026 Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; V…
Initiated 2025-10-10
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-0442-2026 Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers:…
Initiated 2025-10-10
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-0446-2026 DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
Initiated 2025-10-10
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-0445-2026 Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRON…
Initiated 2025-10-10
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-0447-2026 Convenience Kit, BREAST HERNIA DYNJ909125G
Initiated 2025-10-10
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-0451-2026 Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PA…
Initiated 2025-10-10
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-0434-2026 CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM…
Initiated 2025-10-02
Cerenovus Inc
Miami, FL
Class I Ongoing
Z-0154-2026 IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm…
Initiated 2025-10-02
ICU Medical, Inc.
San Clemente, CA
Class I Ongoing
Z-0069-2026 Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding …
Initiated 2025-10-01
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-0161-2026 IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Initiated 2025-09-30
IMPRIS Imaging Inc
Chaska, MN
Class I Ongoing
Z-0164-2026 IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Initiated 2025-09-30
IMPRIS Imaging Inc
Chaska, MN
Class I Ongoing
Z-0070-2026 Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M20…
Initiated 2025-09-30
B BRAUN MEDICAL INC
Allentown, PA
Class I Ongoing
Z-0373-2026 CODMAN Disposable Perforator 11mm. Cranial Perforator.
Initiated 2025-09-26
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class I Ongoing
Z-0031-2026 Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual)…
Initiated 2025-09-17
Percussionaire Corporation
Sandpoint, ID
Class I Ongoing
Z-0136-2026 Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect …
Initiated 2025-09-16
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-0065-2026 EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0035-2026 BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron …
Initiated 2025-09-11
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-0067-2026 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0064-2026 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0047-2026 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0055-2026 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0046-2026 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0048-2026 BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0062-2026 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0050-2026 BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0059-2026 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0053-2026 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0056-2026 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0052-2026 BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0045-2026 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
Initiated 2025-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-2660-2025 MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1…
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2654-2025 Biograph mMR. Model Number: 10433372.
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2664-2025 MAGNETOM Verio. Model Number: 10276755.
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2658-2025 MAGNETOM Lumina (DE). Model Number: 11344916.
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2663-2025 MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Numbe…
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2662-2025 MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2667-2025 MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693,…
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2668-2025 MAGNETOM Vida Fit. Model Number: 11410481.
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2661-2025 MAGNETOM Skyra fit. Model Number: 10849580.
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2656-2025 MAGNETOM Cima.X (DE). Model Number: 11647158.
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2666-2025 MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Initiated 2025-08-28
Siemens Medical Solutions USA, Inc
Malvern, PA
Class I Ongoing
Z-2670-2025 Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Initiated 2025-08-21
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-2481-2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Initiated 2025-08-06
Medtronic Perfusion Systems
Brooklyn Park, MN
Class I Ongoing
Z-2484-2025 ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device …
Initiated 2025-08-06
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-2482-2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Initiated 2025-08-06
Medtronic Perfusion Systems
Brooklyn Park, MN
Class I Ongoing
Z-2610-2025 Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606…
Initiated 2025-07-31
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-2611-2025 Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbe…
Initiated 2025-07-31
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-2612-2025 Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic e…
Initiated 2025-07-31
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-2446-2025 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe…
Initiated 2025-07-24
Dexcom, Inc.
San Diego, CA
Class I Ongoing
Z-2449-2025 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N…
Initiated 2025-07-24
Dexcom, Inc.
San Diego, CA
Class I Ongoing
Z-2326-2025 ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model …
Initiated 2025-07-24
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-2327-2025 RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Mode…
Initiated 2025-07-24
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-2448-2025 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe…
Initiated 2025-07-24
Dexcom, Inc.
San Diego, CA
Class I Ongoing
Z-2450-2025 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe…
Initiated 2025-07-24
Dexcom, Inc.
San Diego, CA
Class I Ongoing
Z-2343-2025 Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen…
Initiated 2025-07-21
Tandem Diabetes Care, Inc.
San Diego, CA
Class I Ongoing
Z-2173-2025 Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Initiated 2025-07-14
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-2460-2025 Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH…
Initiated 2025-07-14
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-2129-2025 Plum Duo Infusion System, List Number: 400020401
Initiated 2025-07-11
ICU Medical, Inc.
Lake Forest, IL
Class I Ongoing
Z-2182-2025 BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02…
Initiated 2025-07-11
Flexicare Medical (Dongguan) Ltd.
Dongguan, N/A
Class I Ongoing
Z-2184-2025 BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Initiated 2025-07-11
Flexicare Medical (Dongguan) Ltd.
Dongguan, N/A
Class I Ongoing
Z-2187-2025 BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Initiated 2025-07-11
Flexicare Medical (Dongguan) Ltd.
Dongguan, N/A
Class I Ongoing
Z-2185-2025 Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Initiated 2025-07-11
Flexicare Medical (Dongguan) Ltd.
Dongguan, N/A
Class I Ongoing
Z-2456-2025 IDM-MICRO-R. Electrical wheelchair component.
Initiated 2025-07-10
mo-Vis BVBA
Nevele, N/A
Class I Ongoing
Z-2454-2025 Micro Joystick R-net. Electrical wheelchair component.
Initiated 2025-07-10
mo-Vis BVBA
Nevele, N/A
Class I Ongoing
Z-2181-2025 Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Re…
Initiated 2025-07-09
Ambu Inc.
Columbia, MD
Class I Ongoing
Z-2180-2025 BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60…
Initiated 2025-07-08
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-2228-2025 DreamStation Auto BiPAP. Non-Continuous Ventilator.
Initiated 2025-06-30
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-2229-2025 DreamStation Auto. Non-Continuous Ventilator.
Initiated 2025-06-30
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-2227-2025 DreamStation Auto CPAP. Non-Continuous Ventilator.
Initiated 2025-06-30
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-2167-2025 Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H…
Initiated 2025-06-26
Hamilton Medical AG Class I Ongoing
Z-2164-2025 Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Contr…
Initiated 2025-06-23
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-2290-2025 Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N…
Initiated 2025-06-23
Thoratec LLC
Pleasanton, CA
Class I Ongoing
Z-2158-2025 SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Initiated 2025-06-16
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-2159-2025 SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Initiated 2025-06-16
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-2161-2025 SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Initiated 2025-06-16
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-2047-2025 Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic…
Initiated 2025-06-03
Given Imaging Ltd.
Yokne'Am Ilit, N/A
Class I Ongoing
Z-2013-2025 Servo-u Ventilator System. Model Number: 6688600.
Initiated 2025-05-30
Maquet Critical Care AB Class I Ongoing
Z-2014-2025 Servo-n Ventilator System. Model Number: 6694800.
Initiated 2025-05-30
Maquet Critical Care AB Class I Ongoing
Z-1959-2025 Extended Tip Applicator, 15 CM, Box of 5.
Initiated 2025-05-22
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class I Ongoing
Z-1958-2025 Extended Tip Applicator, 8CM, Box of 5.
Initiated 2025-05-22
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class I Ongoing
Z-1915-2025 Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA,…
Initiated 2025-05-21
Covidien
Carlsbad, CA
Class I Ongoing
Z-1904-2025 Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36…
Initiated 2025-05-15
SunMed Holdings, LLC
Grand Rapids, MI
Class I Ongoing
Z-2080-2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V…
Initiated 2025-05-14
Edwards Lifesciences, LLC
Irvine, CA
Class I Ongoing
Z-2083-2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A…
Initiated 2025-05-14
Edwards Lifesciences, LLC
Irvine, CA
Class I Ongoing
Z-2084-2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A …
Initiated 2025-05-14
Edwards Lifesciences, LLC
Irvine, CA
Class I Ongoing
Z-1945-2025 Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-…
Initiated 2025-05-12
Dexcom, Inc.
San Diego, CA
Class I Ongoing
Z-1946-2025 Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), …
Initiated 2025-05-12
Dexcom, Inc.
San Diego, CA
Class I Ongoing
Z-2037-2025 BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric pa…
Initiated 2025-05-09
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-2035-2025 BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighin…
Initiated 2025-05-09
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-2036-2025 BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more…
Initiated 2025-05-09
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1865-2025 Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pat…
Initiated 2025-05-07
Zyno Medical LLC
Natick, MA
Class I Ongoing
Z-1868-2025 Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a p…
Initiated 2025-05-07
Zyno Medical LLC
Natick, MA
Class I Ongoing
Z-1717-2025 CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Initiated 2025-04-11
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class I Ongoing
Z-1727-2025 iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate t…
Initiated 2025-04-11
Medical Depot Inc.
Port Washington, NY
Class I Ongoing
Z-1667-2025 CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FO…
Initiated 2025-04-10
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-2483-2025 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Initiated 2025-04-10
3M Company
Saint Paul, MN
Class I Ongoing
Z-1668-2025 CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0…
Initiated 2025-04-10
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1682-2025 CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA…
Initiated 2025-04-10
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1681-2025 CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111…
Initiated 2025-04-10
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1662-2025 CADD Solis HSPCA Pump
Initiated 2025-04-10
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1697-2025 Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/…
Initiated 2025-04-10
Vyaire Medical
Mettawa, IL
Class I Ongoing
Z-1680-2025 Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Initiated 2025-03-27
Bausch & Lomb Surgical, Inc.
Clearwater, FL
Class I Ongoing
Z-1625-2025 GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1632-2025 GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1636-2025 GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1630-2025 GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1627-2025 GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1629-2025 GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1633-2025 GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1626-2025 GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1638-2025 GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1628-2025 GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000
Initiated 2025-03-21
GE Medical Systems China Co., Ltd.
Wuxi, N/A
Class I Ongoing
Z-1528-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Pr…
Initiated 2025-03-19
Avanos Medical, Inc.
Alpharetta, GA
Class I Ongoing
Z-1521-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product D…
Initiated 2025-03-19
Avanos Medical, Inc.
Alpharetta, GA
Class I Ongoing
Z-1523-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product…
Initiated 2025-03-19
Avanos Medical, Inc.
Alpharetta, GA
Class I Ongoing
Z-1570-2025 HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with Hear…
Initiated 2025-03-13
Thoratec LLC
Pleasanton, CA
Class I Ongoing
Z-1493-2025 Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable …
Initiated 2025-03-12
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-1495-2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software…
Initiated 2025-03-12
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-1289-2025 Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035…
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1306-2025 Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 …
Initiated 2025-02-05
Medtronic Perfusion Systems
Brooklyn Park, MN
Class I Ongoing
Z-1244-2025 Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: …
Initiated 2025-02-05
Bard Peripheral Vascular Inc
Tempe, AZ
Class I Ongoing
Z-1246-2025 Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-3…
Initiated 2025-01-30
Micro Therapeutics, Inc.
Irvine, CA
Class I Ongoing
Z-1245-2025 Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-3…
Initiated 2025-01-30
Micro Therapeutics, Inc.
Irvine, CA
Class I Ongoing
Z-1071-2025 Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide S…
Initiated 2025-01-15
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-1145-2025 Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1154-2025 Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1151-2025 Allura CV20; Catalog numbers: 722031
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1160-2025 Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1153-2025 Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1144-2025 Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1146-2025 Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1149-2025 Allura Xper FD20/15; Catalog numbers: 722058
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1155-2025 Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1147-2025 Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class I Ongoing
Z-1070-2025 Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,…
Initiated 2025-01-10
Spectranetics Corporation
Colorado Springs, CO
Class I Ongoing
Z-0992-2025 Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Initiated 2024-12-31
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-0960-2025 VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single P…
Initiated 2024-12-23
Percussionaire Corporation
Sandpoint, ID
Class I Ongoing
Z-0884-2025 Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Initiated 2024-12-20
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0887-2025 Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Initiated 2024-12-20
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0905-2025 Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is design…
Initiated 2024-12-18
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0765-2025 Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,…
Initiated 2024-12-16
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-0823-2025 PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Numb…
Initiated 2024-12-12
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0830-2025 Impella RP Flex with SmartAssist; Product Number: 1000323;
Initiated 2024-12-12
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-0826-2025 VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Initiated 2024-12-12
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0822-2025 ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Num…
Initiated 2024-12-12
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0821-2025 Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 105…
Initiated 2024-12-10
Mercury Enterprises, Inc. dba Mercury Medical
Clearwater, FL
Class I Ongoing
Z-0681-2025 StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati…
Initiated 2024-11-20
Nova Biomedical Corporation
Waltham, MA
Class I Ongoing
Z-0683-2025 StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ket…
Initiated 2024-11-20
Nova Biomedical Corporation
Waltham, MA
Class I Ongoing
Z-0660-2025 Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Micro…
Initiated 2024-11-14
Kirwan Surgical Products, LLC
Marshfield, MA
Class I Ongoing
Z-0658-2025 Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Micros…
Initiated 2024-11-14
Kirwan Surgical Products, LLC
Marshfield, MA
Class I Ongoing
Z-0655-2025 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The D…
Initiated 2024-11-14
Kirwan Surgical Products, LLC
Marshfield, MA
Class I Ongoing
Z-0657-2025 Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar …
Initiated 2024-11-14
Kirwan Surgical Products, LLC
Marshfield, MA
Class I Ongoing
Z-0662-2025 Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAID…
Initiated 2024-11-01
Medtronic Neurosurgery
Fort Worth, TX
Class I Ongoing
Z-0373-2025 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Initiated 2024-10-21
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0375-2025 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Initiated 2024-10-21
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0377-2025 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Initiated 2024-10-21
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0379-2025 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Initiated 2024-10-21
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0378-2025 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Initiated 2024-10-21
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0305-2025 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Componen…
Initiated 2024-10-15
Draeger Medical, Inc.
Telford, PA
Class I Ongoing
Z-0304-2025 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:…
Initiated 2024-10-15
Draeger Medical, Inc.
Telford, PA
Class I Ongoing
Z-0328-2025 BioZorb Marker. Radiographic soft tissue marker.
Initiated 2024-10-10
Hologic, Inc
Marlborough, MA
Class I Ongoing
Z-0292-2025 Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediat…
Initiated 2024-10-07
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0293-2025 Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200…
Initiated 2024-10-07
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0294-2025 Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult pat…
Initiated 2024-10-07
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0310-2025 Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Initiated 2024-09-25
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0092-2025 VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Initiated 2024-09-20
Maquet Cardiovascular, LLC
Wayne, NJ
Class I Ongoing
Z-0005-2025 Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F…
Initiated 2024-09-13
Zyno Medical LLC
Natick, MA
Class I Ongoing
Z-0046-2025 Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3…
Initiated 2024-09-12
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-3153-2024 Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for i…
Initiated 2024-08-30
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-0049-2025 KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco re…
Initiated 2024-08-22
Kinova Inc Class I Ongoing
Z-3208-2024 Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Val…
Initiated 2024-08-21
Percussionaire Corporation
Sandpoint, ID
Class I Ongoing
Z-3207-2024 Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Initiated 2024-08-21
Percussionaire Corporation
Sandpoint, ID
Class I Ongoing
Z-1947-2026 AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits …
Initiated 2026-03-27
North American Rescue LLC.
Greer, SC
Class I Ongoing
Z-1771-2026 Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VA…
Initiated 2026-03-19
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-1770-2026 Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as…
Initiated 2026-03-19
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-2690-2024 Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati…
Initiated 2024-07-25
Breas Medical, Inc.
North Billerica, MA
Class I Ongoing
Z-2587-2024 ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thromb…
Initiated 2024-07-19
Inari Medical - Oak Canyon
Irvine, CA
Class I Ongoing
Z-2944-2024 Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2…
Initiated 2024-07-16
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-2943-2024 Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Initiated 2024-07-16
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0083-2025 Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat…
Initiated 2024-07-12
Datex-Ohmeda, Inc.
Madison, WI
Class I Ongoing
Z-0075-2025 Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to…
Initiated 2024-07-12
Datex-Ohmeda, Inc.
Madison, WI
Class I Ongoing
Z-0080-2025 Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and v…
Initiated 2024-07-12
Datex-Ohmeda, Inc.
Madison, WI
Class I Ongoing
Z-0082-2025 Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to p…
Initiated 2024-07-12
Datex-Ohmeda, Inc.
Madison, WI
Class I Ongoing
Z-0081-2025 Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patie…
Initiated 2024-07-12
Datex-Ohmeda, Inc.
Madison, WI
Class I Ongoing
Z-0074-2025 Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to…
Initiated 2024-07-12
Datex-Ohmeda, Inc.
Madison, WI
Class I Ongoing
Z-2636-2024 McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Initiated 2024-07-09
Covidien
Boulder, CO
Class I Ongoing
Z-1589-2026 Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat…
Initiated 2026-02-18
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-1591-2026 Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller…
Initiated 2026-02-16
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-2249-2024 Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient …
Initiated 2024-06-17
Megadyne Medical Products, Inc.
Blue Ash, OH
Class I Ongoing
Z-2251-2024 BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Initiated 2024-06-12
Synergetics Inc
O Fallon, MO
Class I Ongoing
Z-2252-2024 BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Initiated 2024-06-12
Synergetics Inc
O Fallon, MO
Class I Ongoing
Z-2254-2024 BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye…
Initiated 2024-06-12
Synergetics Inc
O Fallon, MO
Class I Ongoing
Z-2163-2024 SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy…
Initiated 2024-06-05
Philips North America Llc
Cambridge, MA
Class I Ongoing
Z-2321-2024 Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. In…
Initiated 2024-05-30
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-2140-2024 Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes …
Initiated 2024-05-29
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-1826-2026 WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel…
Initiated 2025-12-29
WHILL, INC. Class I Ongoing
Z-1827-2026 WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-ope…
Initiated 2025-12-29
WHILL, INC. Class I Ongoing
Z-2448-2024 Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Number…
Initiated 2024-05-07
ICU Medical Inc
Lake Forest, IL
Class I Ongoing
Z-2130-2024 ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRG…
Initiated 2024-04-30
ZOLL Medical Corporation
Chelmsford, MA
Class I Ongoing
Z-1878-2024 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Initiated 2024-04-29
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-1879-2024 Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Initiated 2024-04-29
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-1880-2024 Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Initiated 2024-04-29
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-1811-2024 Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Initiated 2024-04-18
OptumHealth Care Solutions LLC
Marietta, GA
Class I Ongoing
Z-2443-2024 Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, P…
Initiated 2024-04-08
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1730-2024 Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used …
Initiated 2024-04-08
Vyaire Medical, Inc.
Hochberg, N/A
Class I Ongoing
Z-2444-2024 Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack …
Initiated 2024-04-08
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1015-2026 MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1014-2026 MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1013-2026 MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pac…
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1016-2026 MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1012-2026 MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-1020-2026 FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the Fr…
Initiated 2025-11-24
Abbott Diabetes Care, Inc.
Alameda, CA
Class I Ongoing
Z-1817-2024 OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111…
Initiated 2024-04-01
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1812-2024 BiPAP V30 Auto Ventilator, Part Number 1111178
Initiated 2024-03-26
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1813-2024 BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111…
Initiated 2024-03-26
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1814-2024 BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11…
Initiated 2024-03-26
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0885-2026 Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients…
Initiated 2025-11-14
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-0593-2026 ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the …
Initiated 2025-11-10
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-0591-2026 ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the b…
Initiated 2025-11-10
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-0590-2026 ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the brea…
Initiated 2025-11-10
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-1505-2024 Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Initiated 2024-03-19
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1501-2024 LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Initiated 2024-03-19
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1499-2024 Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Initiated 2024-03-19
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1503-2024 Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Initiated 2024-03-19
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1733-2024 BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ…
Initiated 2024-03-13
Hologic, Inc
Marlborough, MA
Class I Ongoing
Z-0570-2026 Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…
Initiated 2025-10-30
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-1609-2024 t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Initiated 2024-03-05
Tandem Diabetes Care, Inc.
San Diego, CA
Class I Ongoing
Z-1355-2024 Mojo 2 Full Face AAV Non Vented Mask, All Sizes
Initiated 2024-03-01
SleepNet Corporation
Hampton, NH
Class I Ongoing
Z-1692-2024 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Initiated 2024-03-01
Thoratec Corp.
Pleasanton, CA
Class I Ongoing
Z-1356-2024 iQ 2 Nasal Vented Mask
Initiated 2024-03-01
SleepNet Corporation
Hampton, NH
Class I Ongoing
Z-1354-2024 Mojo 2 Full Face Non Vented Mask, All Sizes
Initiated 2024-03-01
SleepNet Corporation
Hampton, NH
Class I Ongoing
Z-1352-2024 Mojo Non Vented Full Face Mask with Headgear, All Sizes
Initiated 2024-03-01
SleepNet Corporation
Hampton, NH
Class I Ongoing
Z-1876-2024 Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF …
Initiated 2024-02-26
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-0488-2026 TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Initiated 2025-10-13
TMJ Solutions Inc
Ventura, CA
Class I Ongoing
Z-1301-2024 HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigationa…
Initiated 2024-02-19
Thoratec Corp.
Pleasanton, CA
Class I Ongoing
Z-1300-2024 HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2…
Initiated 2024-02-19
Thoratec Corp.
Pleasanton, CA
Class I Ongoing
Z-0532-2026 SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PT…
Initiated 2025-10-09
Glycar SA Pty., Ltd.
Irene, N/A
Class I Ongoing
Z-1274-2024 smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Initiated 2024-02-07
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-1275-2024 smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Initiated 2024-02-07
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-0188-2026 Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09…
Initiated 2025-09-25
BALT USA, LLC
Irvine, CA
Class I Ongoing
Z-0043-2026 Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-1…
Initiated 2025-09-18
Cook Medical Incorporated
Bloomington, IN
Class I Ongoing
Z-1324-2024 stay-safe /Luer Lock Adapter 4 in
Initiated 2024-01-23
Fresenius Medical Care Holdings, Inc.
Waltham, MA
Class I Ongoing
Z-1326-2024 stay-safe /Luer Lock Catheter Ext. 18 in
Initiated 2024-01-23
Fresenius Medical Care Holdings, Inc.
Waltham, MA
Class I Ongoing
Z-1327-2024 stay-safe /Luer Catheter Ext. 6 in
Initiated 2024-01-23
Fresenius Medical Care Holdings, Inc.
Waltham, MA
Class I Ongoing
Z-1162-2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used …
Initiated 2024-01-22
Medtronic Neurosurgery
Irvine, CA
Class I Ongoing
Z-1163-2024 Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used…
Initiated 2024-01-22
Medtronic Neurosurgery
Irvine, CA
Class I Ongoing
Z-1166-2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile E…
Initiated 2024-01-22
Medtronic Neurosurgery
Irvine, CA
Class I Ongoing
Z-0112-2026 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Initiated 2025-09-10
Abbott
Plymouth, MN
Class I Ongoing
Z-0110-2026 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Initiated 2025-09-10
Abbott
Plymouth, MN
Class I Ongoing
Z-0109-2026 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Initiated 2025-09-10
Abbott
Plymouth, MN
Class I Ongoing
Z-0028-2026 NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Initiated 2025-09-09
NOXBOX LTD Class I Ongoing
Z-2616-2025 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product De…
Initiated 2025-09-09
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-2617-2025 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product …
Initiated 2025-09-09
Draeger, Inc.
Telford, PA
Class I Ongoing
Z-1186-2024 MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connec…
Initiated 2024-01-16
Avanos Medical, Inc.
Alpharetta, GA
Class I Ongoing
Z-1187-2024 MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -…
Initiated 2024-01-16
Avanos Medical, Inc.
Alpharetta, GA
Class I Ongoing
Z-1062-2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Initiated 2024-01-10
Vyaire Medical
Mettawa, IL
Class I Ongoing
Z-1064-2024 AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Initiated 2024-01-10
Vyaire Medical
Mettawa, IL
Class I Ongoing
Z-1061-2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
Initiated 2024-01-10
Vyaire Medical
Mettawa, IL
Class I Ongoing
Z-1060-2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
Initiated 2024-01-10
Vyaire Medical
Mettawa, IL
Class I Ongoing
Z-1059-2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Initiated 2024-01-10
Vyaire Medical
Mettawa, IL
Class I Ongoing
Z-1063-2024 AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
Initiated 2024-01-10
Vyaire Medical
Mettawa, IL
Class I Ongoing
Z-0318-2026 Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model…
Initiated 2025-08-28
Dexcom, Inc.
San Diego, CA
Class I Ongoing
Z-0842-2024 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. …
Initiated 2024-01-03
Thoratec Corp.
Pleasanton, CA
Class I Ongoing
Z-0089-2026 Model Number L211 PROPONENT DR SL MRI Pacemaker
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0099-2026 Model Number S702, ALTRUA 2 DR SL Pacemaker
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0102-2026 Model Number U128, VALITUDE CRT-P EL MRI
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-2568-2025 Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co…
Initiated 2025-08-20
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-0091-2026 Model Number L231, PROPONENT DR EL MRI Pacemaker
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0093-2026 Model Number L101, ESSENTIO DR SL Pacemaker
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0087-2026 Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0104-2026 Model Number U226, VISIONIST CRT-P EL
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0085-2026 PROPONENT SR SL (Model L200)
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0105-2026 Model Number U228, VISIONIST CRT-P EL MRI
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0090-2026 Model Number L221 PROPONENT DR EL Pacemaker
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0097-2026 Model Number L131, ESSENTIO DR EL MRI Pacemaker
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0084-2026 ACCOLADE DR EL MRI (Model L331)
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0096-2026 Model Number L121 ESSENTIO DR EL Pacemaker
Initiated 2025-08-20
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0858-2024 Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Initiated 2023-12-28
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0849-2024 Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
Initiated 2023-12-28
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0855-2024 Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Initiated 2023-12-28
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0854-2024 Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
Initiated 2023-12-28
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0847-2024 Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
Initiated 2023-12-28
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0852-2024 Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
Initiated 2023-12-28
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0851-2024 Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
Initiated 2023-12-28
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0848-2024 Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
Initiated 2023-12-28
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0980-2024 Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod…
Initiated 2023-12-27
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-2540-2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Whe…
Initiated 2025-08-12
Max Mobility LLC
Lebanon, TN
Class I Ongoing
Z-2538-2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheel…
Initiated 2025-08-12
Max Mobility LLC
Lebanon, TN
Class I Ongoing
Z-2539-2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Whee…
Initiated 2025-08-12
Max Mobility LLC
Lebanon, TN
Class I Ongoing
Z-0864-2024 smiths medical Medfusion Model 4000 syringe pump
Initiated 2023-12-19
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2593-2025 Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Initiated 2025-08-08
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-2592-2025 Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Numbe…
Initiated 2025-08-08
Medline Industries, LP
Northfield, IL
Class I Ongoing
Z-0929-2024 BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4…
Initiated 2023-12-15
Philips North America
Cambridge, MA
Class I Ongoing
Z-0931-2024 BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074…
Initiated 2023-12-15
Philips North America
Cambridge, MA
Class I Ongoing
Z-0930-2024 BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292…
Initiated 2023-12-15
Philips North America
Cambridge, MA
Class I Ongoing
Z-2333-2025 Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Initiated 2025-08-04
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0710-2024 Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Initiated 2023-12-13
Maquet Cardiovascular, LLC
Wayne, NJ
Class I Ongoing
Z-2332-2025 Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Initiated 2025-08-04
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0600-2024 Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M…
Initiated 2023-12-08
Megadyne Medical Products, Inc.
Blue Ash, OH
Class I Ongoing
Z-2431-2025 WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal …
Initiated 2025-07-29
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-2435-2025 WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transsepta…
Initiated 2025-07-29
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-2432-2025 WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal …
Initiated 2025-07-29
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-2429-2025 WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal …
Initiated 2025-07-29
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-2427-2025 WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal…
Initiated 2025-07-29
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-2430-2025 WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal …
Initiated 2025-07-29
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-2566-2025 Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATI…
Initiated 2025-07-25
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-0591-2024 Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap…
Initiated 2023-11-30
Insulet Corporation
Acton, MA
Class I Ongoing
Z-0594-2024 Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Initiated 2023-11-30
Busse Hospital Disposables, Inc.
Hauppauge, NY
Class I Ongoing
Z-0538-2024 AirTouch F20 Full Face Mask and User Guide
Initiated 2023-11-20
ResMed Ltd.
Bella Vista, N/A
Class I Ongoing
Z-0540-2024 AirTouch N20 Nasal Mask and User Guide
Initiated 2023-11-20
ResMed Ltd.
Bella Vista, N/A
Class I Ongoing
Z-0541-2024 AirFit F30 Full Face Mask and User Guide
Initiated 2023-11-20
ResMed Ltd.
Bella Vista, N/A
Class I Ongoing
Z-0536-2024 AirFit N10 Nasal Masks and User Guide
Initiated 2023-11-20
ResMed Ltd.
Bella Vista, N/A
Class I Ongoing
Z-2176-2025 Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Initiated 2025-07-09
B BRAUN MEDICAL INC
Allentown, PA
Class I Ongoing
Z-1090-2024 MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1124-2024 Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1118-2024 Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION T…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1134-2024 Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSE…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1123-2024 Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF …
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1102-2024 MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR C…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1122-2024 Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ90…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1116-2024 Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; …
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1114-2024 Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF D…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1104-2024 MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1096-2024 MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE134…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1119-2024 Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA30…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1117-2024 Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1101-2024 MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, R…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1108-2024 Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1097-2024 MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KI…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1129-2024 Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1106-2024 MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1115-2024 Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYN…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1126-2024 Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1111-2024 Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PA…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1103-2024 MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; …
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1112-2024 Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT2121…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1128-2024 Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION …
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1138-2024 Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1091-2024 MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, …
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1100-2024 MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1110-2024 Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1121-2024 Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NUR…
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1131-2024 Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
Initiated 2023-11-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-0511-2024 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV F…
Initiated 2023-11-06
Nurse Assist, LLC
Haltom City, TX
Class I Ongoing
Z-0355-2024 Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3…
Initiated 2023-11-01
B. Braun Medical, Inc.
Allentown, PA
Class I Ongoing
Z-2095-2025 Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Initiated 2025-06-20
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-2096-2025 Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Initiated 2025-06-20
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-2102-2025 i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngosc…
Initiated 2025-06-17
Intersurgical Inc
East Syracuse, NY
Class I Ongoing
Z-0561-2024 Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster…
Initiated 2023-10-16
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-0194-2024 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Initiated 2023-10-12
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0193-2024 EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Initiated 2023-10-12
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0189-2024 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYM…
Initiated 2023-10-12
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0191-2024 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Initiated 2023-10-12
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0192-2024 EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model…
Initiated 2023-10-12
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0233-2024 VariSoft infusion set, Model Number 1002828
Initiated 2023-10-11
Unomedical A/S
LEJRE, N/A
Class I Ongoing
Z-0075-2024 Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Initiated 2023-09-22
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-0123-2024 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Initiated 2023-09-21
B. Braun Medical, Inc.
Allentown, PA
Class I Ongoing
Z-0124-2024 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Initiated 2023-09-21
B. Braun Medical, Inc.
Allentown, PA
Class I Ongoing
Z-0145-2024 Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Initiated 2023-09-20
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1869-2025 IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intra…
Initiated 2025-05-12
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-0148-2024 Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Initiated 2023-09-20
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0150-2024 Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Initiated 2023-09-20
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0147-2024 Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Initiated 2023-09-20
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0146-2024 Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Initiated 2023-09-20
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0186-2024 Alaris PCA Module 8120
Initiated 2023-09-15
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-0185-2024 BD Alaris Syringe Module, REF 8110
Initiated 2023-09-15
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-0111-2024 Astral 100 and Astral 150 ventilators
Initiated 2023-09-13
ResMed Ltd.
Bella Vista, N/A
Class I Ongoing
Z-0094-2024 Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF…
Initiated 2023-09-11
EITAN MEDICAL LTD
Netanya, N/A
Class I Ongoing
Z-0034-2024 2008T HD SYS. W/O CDX BLUESTAR
Initiated 2023-09-06
Fresenius Medical Care Holdings, Inc.
Waltham, MA
Class I Ongoing
Z-0028-2024 2008T Hemodialysis SYS, with CDX
Initiated 2023-09-06
Fresenius Medical Care Holdings, Inc.
Waltham, MA
Class I Ongoing
Z-0035-2024 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Initiated 2023-09-06
Fresenius Medical Care Holdings, Inc.
Waltham, MA
Class I Ongoing
Z-1767-2025 Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Initiated 2025-04-24
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-1809-2025 Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU C…
Initiated 2025-04-22
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1810-2025 Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Initiated 2025-04-22
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1759-2025 Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Initiated 2025-04-17
C.R. Bard Inc
Covington, GA
Class I Ongoing
Z-1758-2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
Initiated 2025-04-17
C.R. Bard Inc
Covington, GA
Class I Ongoing
Z-1760-2025 Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl…
Initiated 2025-04-11
Centerline Biomedical Inc
Cleveland, OH
Class I Ongoing
Z-1726-2025 Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; …
Initiated 2025-04-07
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0007-2024 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Initiated 2023-08-08
Fresenius Medical Care Holdings, Inc.
Waltham, MA
Class I Ongoing
Z-0006-2024 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Initiated 2023-08-08
Fresenius Medical Care Holdings, Inc.
Waltham, MA
Class I Ongoing
Z-2514-2023 HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Initiated 2023-08-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-2431-2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099…
Initiated 2023-07-31
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2435-2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099…
Initiated 2023-07-31
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2433-2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 099…
Initiated 2023-07-31
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2432-2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Initiated 2023-07-31
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2438-2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Initiated 2023-07-31
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2529-2023 Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Initiated 2023-07-26
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-2526-2023 Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Initiated 2023-07-26
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-2528-2023 Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Initiated 2023-07-26
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-2525-2023 Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Initiated 2023-07-26
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-2530-2023 Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Initiated 2023-07-26
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-2527-2023 Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Initiated 2023-07-26
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-1585-2025 Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product …
Initiated 2025-03-12
Conavi Medical Inc.
Toronto, N/A
Class I Ongoing
Z-2507-2023 Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is a…
Initiated 2023-07-18
Abbott Medical
Plano, TX
Class I Ongoing
Z-2505-2023 Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product …
Initiated 2023-07-18
Abbott Medical
Plano, TX
Class I Ongoing
Z-2510-2023 Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an ele…
Initiated 2023-07-18
Abbott Medical
Plano, TX
Class I Ongoing
Z-2511-2023 Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an ele…
Initiated 2023-07-18
Abbott Medical
Plano, TX
Class I Ongoing
Z-1533-2025 Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (C…
Initiated 2025-03-04
ZOLL Circulation, Inc.
San Jose, CA
Class I Ongoing
Z-2248-2023 Carina Sub-Acute Care Ventilator
Initiated 2023-07-12
Draeger Medical, Inc.
Telford, PA
Class I Ongoing
Z-1519-2025 t:slim X2 Insulin Pump with Interoperable Technology
Initiated 2025-02-27
Tandem Diabetes Care, Inc.
San Diego, CA
Class I Ongoing
Z-1390-2025 Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Initiated 2025-02-26
Covidien
Boulder, CO
Class I Ongoing
Z-1457-2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Initiated 2025-02-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class I Ongoing
Z-1304-2025 BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Initiated 2025-02-18
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-2372-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2388-2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2391-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 88883…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2383-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2371-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 888810200…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2384-2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2379-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2390-2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2376-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2369-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003H…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2378-2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2380-2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2373-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 888810300…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2374-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 888810300…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2377-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2382-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2386-2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2368-2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002H…
Initiated 2023-06-28
Covidien LP
Mansfield, MA
Class I Ongoing
Z-1286-2025 smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1287-2025 smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.…
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1285-2025 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.…
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1284-2025 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8F…
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1282-2025 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.…
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1278-2025 smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer…
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1277-2025 smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1288-2025 smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr…
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-1279-2025 smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., R…
Initiated 2025-02-13
Smiths Medical ASD, Inc.
Minneapolis, MN
Class I Ongoing
Z-2104-2023 The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Initiated 2023-06-15
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-2113-2023 Impella LD intravascular micro axial blood pump, Product Number 005082
Initiated 2023-06-14
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-2112-2023 Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Initiated 2023-06-14
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-2116-2023 Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Initiated 2023-06-14
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-2018-2023 Oxylog 3000 Plus emergency and transport ventilator
Initiated 2023-06-12
Draeger Medical, Inc.
Telford, PA
Class I Ongoing
Z-2012-2023 Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Initiated 2023-06-08
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-2017-2023 Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Initiated 2023-06-08
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-2015-2023 Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Initiated 2023-06-08
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-2014-2023 Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
Initiated 2023-06-08
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-2011-2023 Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Initiated 2023-06-08
Olympus Corporation of the Americas
Center Valley, PA
Class I Ongoing
Z-2149-2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0…
Initiated 2023-06-05
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2150-2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Initiated 2023-06-05
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2151-2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0…
Initiated 2023-06-05
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2152-2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Initiated 2023-06-05
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2001-2023 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Initiated 2023-06-01
Megadyne Medical Products, Inc.
Blue Ash, OH
Class I Ongoing
Z-1999-2023 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Initiated 2023-06-01
Megadyne Medical Products, Inc.
Blue Ash, OH
Class I Ongoing
Z-1997-2023 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
Initiated 2023-06-01
Megadyne Medical Products, Inc.
Blue Ash, OH
Class I Ongoing
Z-1994-2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Initiated 2023-06-01
Megadyne Medical Products, Inc.
Blue Ash, OH
Class I Ongoing
Z-1995-2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
Initiated 2023-06-01
Megadyne Medical Products, Inc.
Blue Ash, OH
Class I Ongoing
Z-1074-2025 Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Fl…
Initiated 2025-01-15
Getinge Usa Sales Inc
Wayne, NJ
Class I Ongoing
Z-1834-2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1875-2023 Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1937-2023 Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1889-2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1905-2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1922-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1892-2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1933-2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1896-2023 RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1959-2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1869-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1930-2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1949-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1926-2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1841-2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1945-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1901-2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1872-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1883-2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1827-2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1833-2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1835-2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1877-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1830-2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1888-2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1865-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1886-2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1954-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1897-2023 RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1957-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1874-2023 Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1958-2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1829-2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1839-2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1847-2023 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1858-2023 Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1859-2023 Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1871-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1887-2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1880-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1873-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1923-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1932-2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1963-2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1867-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1931-2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1842-2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1925-2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1868-2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180065
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1948-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1836-2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1939-2023 Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1844-2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1944-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1950-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1837-2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1940-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1890-2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1941-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1962-2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1899-2023 RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1884-2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1852-2023 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1953-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1946-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1881-2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1956-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1846-2023 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1960-2023 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1942-2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780045
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1851-2023 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
Initiated 2023-05-25
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1019-2025 Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care enviro…
Initiated 2025-01-10
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-1826-2023 ARROW Endurance Extended Dwell Peripheral Catheter System
Initiated 2023-05-19
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-1707-2023 ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1715-2023 ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1722-2023 ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1746-2023 CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1739-2023 CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1732-2023 CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1786-2023 CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1757-2023 CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1769-2023 CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1762-2023 CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1793-2023 ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1752-2023 CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1780-2023 ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1708-2023 ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1822-2023 ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1729-2023 CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1773-2023 CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1817-2023 ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1805-2023 ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1808-2023 ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1718-2023 ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1744-2023 CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1800-2023 ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1749-2023 CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1809-2023 ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1720-2023 ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1755-2023 CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1811-2023 ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1797-2023 ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1798-2023 ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1717-2023 ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1787-2023 CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1794-2023 ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1754-2023 CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1814-2023 ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1728-2023 ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1705-2023 ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1777-2023 CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1704-2023 ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1714-2023 ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1799-2023 ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1807-2023 ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1767-2023 CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1796-2023 ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1734-2023 CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1781-2023 CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1782-2023 CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1731-2023 CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1772-2023 CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1795-2023 ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1713-2023 ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1745-2023 CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1771-2023 CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1721-2023 ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1763-2023 CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1723-2023 ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1804-2023 ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1803-2023 ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1770-2023 CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1725-2023 ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1785-2023 CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1727-2023 ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1815-2023 ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1740-2023 CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1783-2023 CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1758-2023 CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1753-2023 CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1765-2023 CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1812-2023 ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1802-2023 ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1742-2023 CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1741-2023 CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1735-2023 CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1736-2023 CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1816-2023 ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1748-2023 CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1818-2023 ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1719-2023 ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1716-2023 ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1778-2023 CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1759-2023 CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
Initiated 2023-05-10
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1047-2025 regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to …
Initiated 2024-12-26
ROi CPS LLC
Republic, MO
Class I Ongoing
Z-1651-2023 Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, …
Initiated 2023-05-01
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1649-2023 Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110…
Initiated 2023-05-01
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1116-2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheel…
Initiated 2024-12-20
Max Mobility LLC
Lebanon, TN
Class I Ongoing
Z-1590-2023 Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory s…
Initiated 2023-04-17
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-0763-2025 Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Initiated 2024-12-06
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-1630-2023 StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Initiated 2023-04-11
Medtronic Navigation, Inc.
Lafayette, CO
Class I Ongoing
Z-1428-2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G577…
Initiated 2023-04-07
Cook Incorporated
Bloomington, IN
Class I Ongoing
Z-0715-2025 Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Initiated 2024-11-27
Trokamed GmbH Class I Ongoing
Z-1427-2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695)…
Initiated 2023-04-07
Cook Incorporated
Bloomington, IN
Class I Ongoing
Z-0714-2025 Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Initiated 2024-11-27
Trokamed GmbH Class I Ongoing
Z-0713-2025 Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Initiated 2024-11-27
Trokamed GmbH Class I Ongoing
Z-1594-2023 Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-…
Initiated 2023-03-31
SD Biosensor, Inc.
Suwon, N/A
Class I Ongoing
Z-0668-2025 Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstatio…
Initiated 2024-10-15
Draeger Medical, Inc.
Telford, PA
Class I Ongoing
Z-0298-2025 Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Initiated 2024-10-10
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0300-2025 Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Initiated 2024-10-10
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0302-2025 Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Initiated 2024-10-10
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0301-2025 Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Initiated 2024-10-10
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0303-2025 Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number …
Initiated 2024-10-10
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0299-2025 Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Initiated 2024-10-10
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-1275-2023 FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring …
Initiated 2023-02-13
Abbott Diabetes Care, Inc.
Alameda, CA
Class I Ongoing
Z-1274-2023 FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monito…
Initiated 2023-02-13
Abbott Diabetes Care, Inc.
Alameda, CA
Class I Ongoing
Z-1322-2023 Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U…
Initiated 2023-02-10
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1147-2023 Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 099…
Initiated 2023-02-07
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-0227-2025 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inne…
Initiated 2024-09-25
Elekta Instrument AB
Stockholm, N/A
Class I Ongoing
Z-1141-2023 Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Initiated 2023-01-25
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0208-2025 Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi…
Initiated 2024-09-16
Percussionaire Corporation
Sandpoint, ID
Class I Ongoing
Z-1138-2023 NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Initiated 2023-01-23
Draeger Medical, Inc.
Telford, PA
Class I Ongoing
Z-1137-2023 NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Initiated 2023-01-23
Draeger Medical, Inc.
Telford, PA
Class I Ongoing
Z-0047-2025 GE Heathcare Giraffe OmniBed; neo natal incubator
Initiated 2024-09-03
DATEX--OHMEDA, INC.
Wauwatosa, WI
Class I Ongoing
Z-0004-2025 Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Initiated 2024-08-30
Mercury Enterprises, Inc. dba Mercury Medical
Clearwater, FL
Class I Ongoing
Z-3085-2024 Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Initiated 2024-08-20
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-3083-2024 Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Initiated 2024-08-20
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-3084-2024 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Initiated 2024-08-20
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0961-2023 Getinge Flow-e Anesthesia System, Part No. 6887900
Initiated 2022-12-22
Getinge Usa Sales Inc
Wayne, NJ
Class I Ongoing
Z-0960-2023 Getinge Flow-c Anesthesia System, Part No. 6887700
Initiated 2022-12-22
Getinge Usa Sales Inc
Wayne, NJ
Class I Ongoing
Z-0959-2023 Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677…
Initiated 2022-12-22
Getinge Usa Sales Inc
Wayne, NJ
Class I Ongoing
Z-1055-2023 GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, …
Initiated 2022-12-19
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Class I Ongoing
Z-1054-2023 GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20,…
Initiated 2022-12-19
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Class I Ongoing
Z-1057-2023 GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, …
Initiated 2022-12-19
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Class I Ongoing
Z-0885-2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099…
Initiated 2022-12-19
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-1058-2023 GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 86…
Initiated 2022-12-19
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Class I Ongoing
Z-3134-2024 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba…
Initiated 2024-08-08
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-3135-2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba…
Initiated 2024-08-08
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-3137-2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba…
Initiated 2024-08-08
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2721-2024 LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. f…
Initiated 2024-08-01
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-0002-2025 MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1…
Initiated 2024-07-31
Medtronic MiniMed, Inc.
Northridge, CA
Class I Ongoing
Z-0963-2023 CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5)…
Initiated 2022-12-09
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-0962-2023 CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Initiated 2022-12-09
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-0966-2023 CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, …
Initiated 2022-12-09
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-0882-2023 Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 10…
Initiated 2022-12-07
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0877-2023 MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensi…
Initiated 2022-12-07
Covidien LP
Mansfield, MA
Class I Ongoing
Z-2692-2024 FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Initiated 2024-07-24
Abbott Diabetes Care, Inc.
Alameda, CA
Class I Ongoing
Z-0222-2025 CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S…
Initiated 2024-07-16
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2543-2024 RMU-2000 Automated Chest Compression Device
Initiated 2024-07-12
Defibtech, LLC
Guilford, CT
Class I Ongoing
Z-0237-2023 Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
Initiated 2022-10-24
Whele LLC DBA Perch
Boston, MA
Class I Ongoing
Z-0238-2023 Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
Initiated 2022-10-24
Whele LLC DBA Perch
Boston, MA
Class I Ongoing
Z-0236-2023 Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
Initiated 2022-10-24
Whele LLC DBA Perch
Boston, MA
Class I Ongoing
Z-3086-2024 smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item…
Initiated 2024-06-07
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-3088-2024 smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as foll…
Initiated 2024-06-07
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-3087-2024 smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as foll…
Initiated 2024-06-07
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2974-2024 Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Initiated 2024-05-31
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-3090-2024 paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Initiated 2024-05-31
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2319-2024 Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Initiated 2024-05-31
Abiomed, Inc.
Danvers, MA
Class I Ongoing
Z-2599-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Produ…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2614-2024 a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDI…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2600-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH N…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2602-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List …
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2592-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/L…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2598-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2612-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2601-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Pro…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2591-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2608-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Pro…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2606-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2615-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/L…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2596-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/Li…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2590-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2605-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List N…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2589-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Num…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2594-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List …
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2603-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2613-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Produ…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2607-2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Cod…
Initiated 2024-05-29
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-1783-2022 Wisp and Wisp Youth Nasal Mask
Initiated 2022-09-06
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1782-2022 DreamWisp Nasal Mask with Over the Nose Cushion
Initiated 2022-09-06
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1780-2022 Philips Respironics Amara View Minimal Contact Full-Face Mask
Initiated 2022-09-06
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0074-2023 Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-u…
Initiated 2022-08-29
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-0075-2023 Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; …
Initiated 2022-08-29
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-0072-2023 Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filte…
Initiated 2022-08-29
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-0077-2023 Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube a…
Initiated 2022-08-29
TELEFLEX LLC
Morrisville, NC
Class I Ongoing
Z-1535-2024 AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Initiated 2024-03-25
SonarMed Inc
Carmel, IN
Class I Ongoing
Z-1666-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1642-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1680-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1639-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1649-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1521-2024 AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Initiated 2024-03-21
SonarMed Inc
Carmel, IN
Class I Ongoing
Z-1659-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1519-2024 AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Initiated 2024-03-21
SonarMed Inc
Carmel, IN
Class I Ongoing
Z-1655-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1673-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1675-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1640-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1679-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1643-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1667-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1670-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1685-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1644-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1652-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1681-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1682-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1520-2024 AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Initiated 2024-03-21
SonarMed Inc
Carmel, IN
Class I Ongoing
Z-1683-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1678-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1676-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1661-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1665-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1658-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1646-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1648-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1650-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1656-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1641-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1669-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1684-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1668-2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
Initiated 2024-03-21
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1464-2024 VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; …
Initiated 2024-03-14
Biomerieux Inc
Hazelwood, MO
Class I Ongoing
Z-1560-2022 Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number …
Initiated 2022-07-20
Getinge Usa Sales Inc
Wayne, NJ
Class I Ongoing
Z-1612-2024 Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices int…
Initiated 2024-03-08
ROUTE 92 MEDICAL INC
San Mateo, CA
Class I Ongoing
Z-1613-2024 Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional de…
Initiated 2024-03-08
ROUTE 92 MEDICAL INC
San Mateo, CA
Class I Ongoing
Z-1611-2024 Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventio…
Initiated 2024-03-08
ROUTE 92 MEDICAL INC
San Mateo, CA
Class I Ongoing
Z-1610-2024 Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional dev…
Initiated 2024-03-08
ROUTE 92 MEDICAL INC
San Mateo, CA
Class I Ongoing
Z-1614-2024 Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i…
Initiated 2024-03-08
ROUTE 92 MEDICAL INC
San Mateo, CA
Class I Ongoing
Z-1484-2024 LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Initiated 2024-03-07
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-1485-2024 Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Initiated 2024-03-06
Outset Medical, Inc.
San Jose, CA
Class I Ongoing
Z-2421-2024 CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following u…
Initiated 2024-02-27
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-1374-2024 Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Initiated 2024-02-20
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-1512-2022 HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Initiated 2022-06-28
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-1525-2022 HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Initiated 2022-06-27
Hamilton Medical AG Class I Ongoing
Z-1382-2024 GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Initiated 2024-02-13
DeRoyal Industries Inc
Powell, TN
Class I Ongoing
Z-1284-2024 CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-cathe…
Initiated 2024-02-02
Medos International Sarl
Le Locle, N/A
Class I Ongoing
Z-1312-2022 Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialy…
Initiated 2022-06-08
Covidien Llc
Mansfield, MA
Class I Ongoing
Z-1315-2022 Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, …
Initiated 2022-06-08
Covidien Llc
Mansfield, MA
Class I Ongoing
Z-1317-2022 Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion…
Initiated 2022-06-08
Covidien Llc
Mansfield, MA
Class I Ongoing
Z-1318-2022 Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusio…
Initiated 2022-06-08
Covidien Llc
Mansfield, MA
Class I Ongoing
Z-1320-2022 Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresi…
Initiated 2022-06-08
Covidien Llc
Mansfield, MA
Class I Ongoing
Z-1211-2022 Drager SafeStar 55, Catalog No. MP01790
Initiated 2022-05-16
Draeger Medical, Inc.
Telford, PA
Class I Ongoing
Z-0775-2024 EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Initiated 2023-12-29
Datex-Ohmeda, Inc.
Madison, WI
Class I Ongoing
Z-0957-2024 GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000…
Initiated 2023-12-26
Wipro GE Healthcare Private Ltd.
Bengaluru, N/A
Class I Ongoing
Z-1266-2022 HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Initiated 2022-05-05
Medtronic Inc
Minneapolis, MN
Class I Ongoing
Z-0960-2024 GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
Initiated 2023-12-26
Wipro GE Healthcare Private Ltd.
Bengaluru, N/A
Class I Ongoing
Z-0962-2024 GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
Initiated 2023-12-26
Wipro GE Healthcare Private Ltd.
Bengaluru, N/A
Class I Ongoing
Z-1081-2024 Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Initiated 2023-12-22
Windstone Medical Packaging, Inc.
Billings, MT
Class I Ongoing
Z-1080-2024 Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Initiated 2023-12-22
Windstone Medical Packaging, Inc.
Billings, MT
Class I Ongoing
Z-1082-2024 Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Initiated 2023-12-22
Windstone Medical Packaging, Inc.
Billings, MT
Class I Ongoing
Z-1520-2022 NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Initiated 2022-04-29
Medtronic Xomed, Inc.
Jacksonville, FL
Class I Ongoing
Z-0863-2024 smiths medical Medfusion Model 3500 Syringe pump
Initiated 2023-12-19
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-0637-2024 High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Initiated 2023-12-12
Percussionaire Corporation
Sandpoint, ID
Class I Ongoing
Z-1272-2022 Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-8…
Initiated 2022-04-18
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-1271-2022 Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 40…
Initiated 2022-04-18
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-1227-2022 Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engst…
Initiated 2022-04-18
GE Healthcare, LLC
Waukesha, WI
Class I Ongoing
Z-1207-2022 HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Initiated 2022-04-14
Medtronic Inc
Minneapolis, MN
Class I Ongoing
Z-1049-2024 Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1044-2024 TRACH KIT W/HYDROGEN & SALI
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1045-2024 Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED…
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1051-2024 Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1048-2024 Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400…
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1050-2024 Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 4…
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1047-2024 Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILIC…
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1043-2024 Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chi…
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-1046-2024 Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML B…
Initiated 2023-12-04
Cardinal Health 200, LLC
Waukegan, IL
Class I Ongoing
Z-0549-2024 Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Initiated 2023-11-29
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-0505-2024 Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst…
Initiated 2023-11-17
Philips North America Llc
Cambridge, MA
Class I Ongoing
Z-0966-2022 Puritan Bennett 980 Series Ventilator
Initiated 2022-03-25
Medtronic formerly Covidien Class I Ongoing
Z-0918-2022 Cub 2 Enclosed Bed Canopy System
Initiated 2022-03-14
Sensory Medical Inc
Lakewood, CO
Class I Ongoing
Z-0927-2022 Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation Syst…
Initiated 2022-03-02
Medtronic Inc
Minneapolis, MN
Class I Ongoing
Z-0909-2022 Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United State…
Initiated 2022-02-28
Respironics California, LLC
Carlsbad, CA
Class I Ongoing
Z-0908-2022 Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Initiated 2022-02-28
Respironics California, LLC
Carlsbad, CA
Class I Ongoing
Z-0907-2022 Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709…
Initiated 2022-02-28
Respironics California, LLC
Carlsbad, CA
Class I Ongoing
Z-0717-2022 Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Initiated 2022-01-13
Lusys Laboratories, Inc.
San Diego, CA
Class I Ongoing
Z-2631-2023 Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) …
Initiated 2023-08-25
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0529-2022 Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Initiated 2021-12-29
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-0004-2024 Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet,…
Initiated 2023-08-10
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0002-2024 Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intra…
Initiated 2023-08-10
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0337-2022 Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-08…
Initiated 2021-11-15
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-2142-2023 HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatr…
Initiated 2023-06-15
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-2140-2023 HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory sup…
Initiated 2023-06-15
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-2141-2023 HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and opt…
Initiated 2023-06-15
Hamilton Medical, Inc.
Reno, NV
Class I Ongoing
Z-2028-2023 TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
Initiated 2023-05-19
GE Healthcare Finland Oy
Helsinki, N/A
Class I Ongoing
Z-2027-2023 TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Initiated 2023-05-19
GE Healthcare Finland Oy
Helsinki, N/A
Class I Ongoing
Z-2034-2023 TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
Initiated 2023-05-19
GE Healthcare Finland Oy
Helsinki, N/A
Class I Ongoing
Z-2032-2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia dete…
Initiated 2023-05-19
GE Healthcare Finland Oy
Helsinki, N/A
Class I Ongoing
Z-0118-2022 ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments hold…
Initiated 2021-09-22
MEDTECH SAS
Montpellier, N/A
Class I Ongoing
Z-0091-2022 Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IA…
Initiated 2021-09-21
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-0010-2022 Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following …
Initiated 2021-09-07
DJO, LLC
Carlsbad, CA
Class I Ongoing
Z-2583-2021 EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Ec…
Initiated 2021-08-27
North Coast Medical Inc
Morgan Hill, CA
Class I Ongoing
Z-2582-2021 Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL…
Initiated 2021-08-27
North Coast Medical Inc
Morgan Hill, CA
Class I Ongoing
Z-0068-2022 ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Initiated 2021-08-24
National Distribution & Contracting Inc
La Vergne, TN
Class I Ongoing
Z-0067-2022 ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultra…
Initiated 2021-08-24
National Distribution & Contracting Inc
La Vergne, TN
Class I Ongoing
Z-0029-2022 Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to…
Initiated 2021-08-23
Aesthetics Systems Usa Inc
Corona, CA
Class I Ongoing
Z-0224-2022 Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Initiated 2021-08-18
Scrip Inc
Peoria, IL
Class I Ongoing
Z-2480-2021 EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmiss…
Initiated 2021-08-12
AMTEC SALES Inc
Miami, FL
Class I Ongoing
Z-0088-2022 EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Initiated 2021-08-11
Red Medical Supplies
Vancouver, N/A
Class I Ongoing
Z-0089-2022 EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Initiated 2021-08-11
Red Medical Supplies
Vancouver, N/A
Class I Ongoing
Z-0090-2022 EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Initiated 2021-08-11
Red Medical Supplies
Vancouver, N/A
Class I Ongoing
Z-2377-2021 NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Initiated 2021-08-06
Smiths Medical ASD Inc.
Minneapolis, MN
Class I Ongoing
Z-2286-2021 Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indic…
Initiated 2021-08-04
Cardinal Health
Mansfield, MA
Class I Ongoing
Z-2285-2021 Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indi…
Initiated 2021-08-04
Cardinal Health
Mansfield, MA
Class I Ongoing
Z-2284-2021 Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is ind…
Initiated 2021-08-04
Cardinal Health
Mansfield, MA
Class I Ongoing
Z-1489-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Initiated 2023-03-24
Cordis US Corp
Miami Lakes, FL
Class I Ongoing
Z-1490-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
Initiated 2023-03-24
Cordis US Corp
Miami Lakes, FL
Class I Ongoing
Z-1487-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
Initiated 2023-03-24
Cordis US Corp
Miami Lakes, FL
Class I Ongoing
Z-1494-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
Initiated 2023-03-24
Cordis US Corp
Miami Lakes, FL
Class I Ongoing
Z-1495-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
Initiated 2023-03-24
Cordis US Corp
Miami Lakes, FL
Class I Ongoing
Z-1484-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
Initiated 2023-03-24
Cordis US Corp
Miami Lakes, FL
Class I Ongoing
Z-1565-2023 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Initiated 2023-03-22
ICU Medical Inc
Lake Forest, IL
Class I Ongoing
Z-1567-2023 ASM Replacement Battery, Component Number SUB0000864
Initiated 2023-03-22
ICU Medical Inc
Lake Forest, IL
Class I Ongoing
Z-1568-2023 ASM Replacement Battery, Component Number SUB0000594
Initiated 2023-03-22
ICU Medical Inc
Lake Forest, IL
Class I Ongoing
Z-1313-2023 Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Initiated 2023-03-10
Fresenius Kabi USA, LLC
North Andover, MA
Class I Ongoing
Z-2074-2021 Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator…
Initiated 2021-06-18
Respironics California, LLC
Carlsbad, CA
Class I Ongoing
Z-1956-2021 Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Initiated 2021-06-14
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1958-2021 A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Initiated 2021-06-14
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1359-2020 CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Initiated 2020-02-04
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-1567-2020 LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Ov…
Initiated 2020-03-23
LeMaitre Vascular, Inc.
Burlington, MA
Class I Ongoing
Z-2451-2019 Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: …
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-2190-2021 HeartWare HVAD Pump Implant Kit, REF 1125
Initiated 2021-06-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2456-2019 Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact…
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-1555-2020 Imager II 5F Angiographic Catheters, 5 units per package.
Initiated 2020-02-11
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-2463-2019 Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Br…
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-1362-2020 CareFusion Alaris PCA Module, Model 8120
Initiated 2020-02-04
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-1531-2021 ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers …
Initiated 2021-03-15
St. Jude Medical, Cardian Rhythm Management Division
Sylmar, CA
Class I Ongoing
Z-1832-2017 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the drive…
Initiated 2017-03-10
Heartware
Miami Lakes, FL
Class I Ongoing
Z-0099-2019 Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Initiated 2018-09-20
Maquet Datascope Corp - Cardiac Assist Division
Mahwah, NJ
Class I Ongoing
Z-2191-2021 HeartWare HVAD Pump Implant Kit, REF 1153
Initiated 2021-06-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-1306-2021 Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT C…
Initiated 2021-02-03
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-2196-2021 HeartWare HVAD Outflow Graft, REF MCS1725OG
Initiated 2021-06-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-1309-2021 BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Mo…
Initiated 2021-03-03
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-0100-2019 Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Initiated 2018-09-20
Maquet Datascope Corp - Cardiac Assist Division
Mahwah, NJ
Class I Ongoing
Z-1539-2021 COVID-19 Self-Test Kit *** INNOVA *** 3T
Initiated 2021-04-09
INNOVA MEDICAL GROUP, INC.
Pasadena, CA
Class I Ongoing
Z-2197-2021 HeartWare HVAD Pump Accessories, REF MCS1753AK
Initiated 2021-06-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-1201-2021 Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Initiated 2021-02-12
Medtronic Vascular, Inc.
Santa Rosa, CA
Class I Ongoing
Z-2465-2019 Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH an…
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-0946-2021 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model …
Initiated 2020-11-19
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-1942-2019 CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
Initiated 2019-06-17
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-1941-2019 CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
Initiated 2019-06-17
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-1360-2020 CareFusion Alaris Pump Module, Model 8100
Initiated 2020-02-04
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-1944-2019 CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
Initiated 2019-06-17
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-1313-2021 Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1…
Initiated 2021-03-03
Medtronic Perfusion Systems
Brooklyn Park, MN
Class I Ongoing
Z-2460-2019 Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF …
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-1361-2020 CareFusion Alaris Syringe Module, Model 8110
Initiated 2020-02-04
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-1698-2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. …
Initiated 2015-04-29
HeartWare Inc
Miami Lakes, FL
Class I Ongoing
Z-1538-2021 For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT…
Initiated 2021-04-09
INNOVA MEDICAL GROUP, INC.
Pasadena, CA
Class I Ongoing
Z-2453-2019 Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-12…
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-2462-2019 Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft…
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-2458-2019 McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation …
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-1939-2019 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Initiated 2019-06-17
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-1903-2018 Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Pro…
Initiated 2018-05-02
Heartware
Miami Lakes, FL
Class I Ongoing
Z-1943-2019 CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
Initiated 2019-06-17
Datascope Corp.
Mahwah, NJ
Class I Ongoing
Z-1591-2021 VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous va…
Initiated 2021-04-12
Boston Scientific Corporation
Maple Grove, MN
Class I Ongoing
Z-2192-2021 HeartWare HVAD Driveline Extension Cable, REF 100
Initiated 2021-06-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2454-2019 Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numb…
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-2188-2021 HeartWare HVAD Pump Implant Kit, REF 1103
Initiated 2021-06-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2189-2021 HeartWare HVAD Pump Implant Kit, REF 1104
Initiated 2021-06-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2194-2021 HeartWare HVAD Implant Kit, REF 1104JP
Initiated 2021-06-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-3086-2017 CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducin…
Initiated 2017-07-17
Maquet Datascope Corp - Cardiac Assist Division
Mahwah, NJ
Class I Ongoing
Z-2457-2019 Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle …
Initiated 2019-07-24
Allergan PLC
Irvine, CA
Class I Ongoing
Z-1966-2026 Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1968-2026 Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe…
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1958-2026 Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. …
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1955-2026 Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):…
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1960-2026 Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782…
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1951-2026 Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1957-2026 Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1963-2026 Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821…
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1959-2026 Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105…
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1952-2026 Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1956-2026 Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. …
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1964-2026 Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Initiated 2026-04-14
Philips North America
Cambridge, MA
Class II Ongoing
Z-1982-2026 BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Initiated 2026-04-07
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-1988-2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Initiated 2026-04-03
DEPUY (IRELAND) Class II Ongoing
Z-1986-2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Initiated 2026-04-03
DEPUY (IRELAND) Class II Ongoing
Z-1991-2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Initiated 2026-04-03
DEPUY (IRELAND) Class II Ongoing
Z-1993-2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Initiated 2026-04-03
DEPUY (IRELAND) Class II Ongoing
Z-1987-2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Initiated 2026-04-03
DEPUY (IRELAND) Class II Ongoing
Z-2003-2026 Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Initiated 2026-04-02
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-2001-2026 i-STAT G3+ cartridge; List Number: 03P78-26;
Initiated 2026-04-01
Abbott Point Of Care Inc.
Princeton, NJ
Class II Ongoing
Z-1999-2026 i-STAT EG7+ cartridge; List Number: 03P76-25;
Initiated 2026-04-01
Abbott Point Of Care Inc.
Princeton, NJ
Class II Ongoing
Z-1918-2026 Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Initiated 2026-03-27
Micro-X Ltd.
Tonsley, N/A
Class II Ongoing
Z-1984-2026 Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens …
Initiated 2026-03-26
Immuno-Mycologics, Inc
Norman, OK
Class II Ongoing
Z-1903-2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Initiated 2026-03-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1901-2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Initiated 2026-03-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1907-2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Initiated 2026-03-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1902-2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Initiated 2026-03-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1908-2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Initiated 2026-03-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1906-2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Initiated 2026-03-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1896-2026 Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Initiated 2026-03-25
Davol, Inc.
Warwick, RI
Class II Ongoing
Z-1900-2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Initiated 2026-03-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1806-2026 Yeastone Broth, 11ML, 10/BOX YY3462
Initiated 2026-03-24
Remel, Inc
Lenexa, KS
Class II Ongoing
Z-1949-2026 Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: …
Initiated 2026-03-23
Hologic, Inc
Marlborough, MA
Class II Ongoing
Z-1823-2026 Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Initiated 2026-03-23
Gentuity, LLC
Sudbury, MA
Class II Ongoing
Z-1950-2026 Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5…
Initiated 2026-03-23
Advanced Bionics, LLC
Valencia, CA
Class II Ongoing
Z-1820-2026 Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Initiated 2026-03-19
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-1805-2026 Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended…
Initiated 2026-03-19
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-1816-2026 Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Initiated 2026-03-19
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-1980-2026 Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Initiated 2026-03-18
Siemens Healthcare Diagnostics, Inc.
Newark, DE
Class II Ongoing
Z-1632-2026 Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Initiated 2026-03-17
Straumann USA LLC
Andover, MA
Class II Ongoing
Z-2040-2026 Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline…
Initiated 2026-03-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2045-2026 Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVEL…
Initiated 2026-03-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2041-2026 Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE …
Initiated 2026-03-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1924-2026 Flamingo Funnel Small, Model Number SQ20012-01
Initiated 2026-03-16
SurgiSmoke Solutions
Saint Paul, MN
Class II Ongoing
Z-1922-2026 Access Total T4 Calibrator, Catalog No. 33805
Initiated 2026-03-16
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-2043-2026 Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV …
Initiated 2026-03-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2042-2026 Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE T…
Initiated 2026-03-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1925-2026 Flamingo Funnel Medium, Model Number SQ20012-02
Initiated 2026-03-16
SurgiSmoke Solutions
Saint Paul, MN
Class II Ongoing
Z-1824-2026 CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Initiated 2026-03-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1894-2026 LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following mat…
Initiated 2026-03-13
Magellan Diagnostics, Inc.
North Billerica, MA
Class II Ongoing
Z-1893-2026 (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit …
Initiated 2026-03-13
Magellan Diagnostics, Inc.
North Billerica, MA
Class II Ongoing
Z-1895-2026 LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following mat…
Initiated 2026-03-13
Magellan Diagnostics, Inc.
North Billerica, MA
Class II Ongoing
Z-1996-2026 iLet Bionic Pancreas, REF: BB1001
Initiated 2026-03-12
Beta Bionics, Inc.
Irvine, CA
Class II Ongoing
Z-1943-2026 Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Initiated 2026-03-12
Healthmark Industries Co., Inc.
Fraser, MI
Class II Ongoing
Z-1916-2026 MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206…
Initiated 2026-03-11
ARROW INTERNATIONAL, LLC
Morrisville, NC
Class II Ongoing
Z-1920-2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Initiated 2026-03-11
Windstone Medical Packaging, Inc.
Billings, MT
Class II Ongoing
Z-1911-2026 ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J…
Initiated 2026-03-11
ARROW INTERNATIONAL, LLC
Morrisville, NC
Class II Ongoing
Z-1914-2026 ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code:…
Initiated 2026-03-11
ARROW INTERNATIONAL, LLC
Morrisville, NC
Class II Ongoing
Z-1913-2026 FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: …
Initiated 2026-03-11
ARROW INTERNATIONAL, LLC
Morrisville, NC
Class II Ongoing
Z-1912-2026 PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)2…
Initiated 2026-03-11
ARROW INTERNATIONAL, LLC
Morrisville, NC
Class II Ongoing
Z-1921-2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Initiated 2026-03-11
Windstone Medical Packaging, Inc.
Billings, MT
Class II Ongoing
Z-1915-2026 Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531…
Initiated 2026-03-11
ARROW INTERNATIONAL, LLC
Morrisville, NC
Class II Ongoing
Z-1811-2026 Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
Initiated 2026-03-10
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Komorniki, N/A
Class II Ongoing
Z-1653-2026 ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Initiated 2026-03-10
Siemens Medical Solutions USA, Inc
Malvern, PA
Class II Ongoing
Z-1933-2026 LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
Initiated 2026-03-09
LSL Healthcare Inc.
Niles, IL
Class II Ongoing
Z-1930-2026 LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Initiated 2026-03-09
LSL Healthcare Inc.
Niles, IL
Class II Ongoing
Z-1944-2026 VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Initiated 2026-03-09
Milestone S.R.L. Class II Ongoing
Z-1929-2026 LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
Initiated 2026-03-09
LSL Healthcare Inc.
Niles, IL
Class II Ongoing
Z-1928-2026 LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
Initiated 2026-03-09
LSL Healthcare Inc.
Niles, IL
Class II Ongoing
Z-1932-2026 LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Initiated 2026-03-09
LSL Healthcare Inc.
Niles, IL
Class II Ongoing
Z-1825-2026 Philips Spectral CT on Rails. Model Number: 728334.
Initiated 2026-03-07
PHILIPS MEDICAL SYSTEMS
Cambridge, MA
Class II Ongoing
Z-0831-2025 nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with th…
Initiated 2024-12-11
Nuwellis Inc
Eden Prairie, MN
Class I Completed
Z-1828-2026 CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Initiated 2026-03-06
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-1769-2026 Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max …
Initiated 2026-03-05
Tornier, Inc
Bloomington, MN
Class II Ongoing
Z-1862-2026 Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/U…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1873-2026 AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1664-2026 ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1863-2026 Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Pro…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1672-2026 Allura Xper FD20/15 OR Table; System Code: 722059;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1673-2026 Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1866-2026 Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1812-2026 Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Initiated 2026-03-03
Wilson-Cook Medical Inc.
Winston Salem, NC
Class II Ongoing
Z-1676-2026 Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1872-2026 AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; …
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1679-2026 Azurion 5 M12; System Code: (1)722227, (2)722231;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1859-2026 Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1766-2026 OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Initiated 2026-03-03
Oxoid Australia Pty Limited Class II Ongoing
Z-1666-2026 ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1660-2026 ALLURA Xper FD10F; System Code: 722002;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1871-2026 Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/U…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1858-2026 Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Produ…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1668-2026 Allura Xper FD20/10; System Code: 722029;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1860-2026 Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Prod…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1864-2026 Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Prod…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1665-2026 ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1674-2026 Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1677-2026 Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Initiated 2026-03-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1875-2026 AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; …
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1870-2026 Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Produ…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1856-2026 Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Produc…
Initiated 2026-03-03
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1767-2026 SIGNA Premier systems
Initiated 2026-02-27
GE Healthcare LLC
Florence, SC
Class II Ongoing
Z-1885-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ90939…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1878-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMI…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1884-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B …
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1883-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits conta…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1876-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 AN…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1886-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART …
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1892-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1694-2026 Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/…
Initiated 2026-02-27
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1888-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1887-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C …
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1877-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1882-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ8034…
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1889-2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Initiated 2026-02-27
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1838-2026 Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1829-2026 Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM AN…
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1835-2026 Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF,…
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1834-2026 Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGR…
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1702-2026 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Initiated 2026-02-25
Synthes (USA) Products LLC
West Chester, PA
Class II Ongoing
Z-1642-2026 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Prod…
Initiated 2026-02-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1847-2026 Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1836-2026 Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model…
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1643-2026 Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 92000…
Initiated 2026-02-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1839-2026 Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, …
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1830-2026 Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1640-2026 Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Pro…
Initiated 2026-02-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1841-2026 Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1845-2026 Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1833-2026 Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model N…
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1840-2026 Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1638-2026 Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Ca…
Initiated 2026-02-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1850-2026 Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1849-2026 Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069…
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1842-2026 Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLAND…
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1831-2026 Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, M…
Initiated 2026-02-25
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1657-2026 Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Initiated 2026-02-23
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-1821-2026 Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL …
Initiated 2026-02-20
Clariance-SAS
Beaurains, N/A
Class II Ongoing
Z-1634-2026 Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Sim…
Initiated 2026-02-19
AMO Puerto Rico Manufacturing, Inc.
Anasco, PR
Class II Ongoing
Z-1685-2026 Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150…
Initiated 2026-02-18
Mentor Texas, LP.
Irving, TX
Class II Ongoing
Z-1684-2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Sm…
Initiated 2026-02-18
Mentor Texas, LP.
Irving, TX
Class II Ongoing
Z-1581-2026 Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksel…
Initiated 2026-02-18
Elekta, Inc.
Atlanta, GA
Class II Ongoing
Z-1681-2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tis…
Initiated 2026-02-18
Mentor Texas, LP.
Irving, TX
Class II Ongoing
Z-1682-2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650…
Initiated 2026-02-18
Mentor Texas, LP.
Irving, TX
Class II Ongoing
Z-1686-2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-1…
Initiated 2026-02-18
Mentor Texas, LP.
Irving, TX
Class II Ongoing
Z-1580-2026 Cub Pediatric Crib, Model FL19H
Initiated 2026-02-18
Stryker Medical Division of Stryker Corporation
Portage, MI
Class II Ongoing
Z-1586-2026 Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima …
Initiated 2026-02-18
Hologic, Inc.
San Diego, CA
Class II Ongoing
Z-1683-2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCP…
Initiated 2026-02-18
Mentor Texas, LP.
Irving, TX
Class II Ongoing
Z-1687-2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth …
Initiated 2026-02-18
Mentor Texas, LP.
Irving, TX
Class II Ongoing
Z-1774-2026 See Luer Cap Set, MPC-130, set, administration, intravascular
Initiated 2026-02-17
Molded Products Inc
Harlan, IA
Class II Ongoing
Z-1707-2026 THORACIC ROBOTS, DYNJ908777B
Initiated 2026-02-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1705-2026 Airway Exam Kit, DYKE1796
Initiated 2026-02-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1709-2026 Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY K…
Initiated 2026-02-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1710-2026 Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ9…
Initiated 2026-02-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1582-2026 Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Initiated 2026-02-16
ConvaTec, Inc
Greensboro, NC
Class II Ongoing
Z-1583-2026 Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Initiated 2026-02-16
ConvaTec, Inc
Greensboro, NC
Class II Ongoing
Z-1745-2026 MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1749-2026 Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1752-2026 Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1747-2026 MiniMed 620G Insulin Pump (MMT-1750)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1748-2026 Paradigm Insulin Pump (MMT-712, MMT-715)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1746-2026 MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1750-2026 Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1691-2026 Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCH…
Initiated 2026-02-13
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1690-2026 ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Initiated 2026-02-13
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1751-2026 MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1741-2026 MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1743-2026 MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1740-2026 MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Initiated 2026-02-13
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1610-2026 Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Initiated 2026-02-12
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1613-2026 Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Initiated 2026-02-12
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1612-2026 Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Initiated 2026-02-12
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1611-2026 Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Initiated 2026-02-12
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1757-2026 Burlington Medical, Wrap Aprons.
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1761-2026 Burlington Medical, Leg Wraps.
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1762-2026 Burlington Medical, Half Aprons.
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1754-2026 Burlington Medical, Vest
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1763-2026 Burlington Medical, Demi Half Aprons.
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1645-2026 BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Initiated 2026-02-11
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-1765-2026 Burlington Medical, Kilt Blockers.
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1759-2026 Burlington Medical, Protective Sleeves.
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1756-2026 Burlington Medical, Frontal Aprons
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1764-2026 Burlington Medical, Blockers.
Initiated 2026-02-11
Burlington Medical, LLC
Newport News, VA
Class II Ongoing
Z-1629-2026 Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Initiated 2026-02-10
Orthalign, Inc
Aliso Viejo, CA
Class II Ongoing
Z-1630-2026 Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Initiated 2026-02-10
Orthalign, Inc
Aliso Viejo, CA
Class II Ongoing
Z-1574-2026 Artegraft Vascular Graft; REF#: AG740;
Initiated 2026-02-10
LeMaitre Vascular, Inc.
North Brunswick, NJ
Class II Ongoing
Z-1565-2026 Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Descri…
Initiated 2026-02-09
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME
Class II Ongoing
Z-1554-2026 Artelon FlexBand Dynamic Matrix Ref: 31057
Initiated 2026-02-06
International Life Sciences
Atlanta, GA
Class II Ongoing
Z-1556-2026 Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEX…
Initiated 2026-02-06
International Life Sciences
Atlanta, GA
Class II Ongoing
Z-1555-2026 Artelon FlexBand Plus Ref: 41054 & 41057
Initiated 2026-02-06
International Life Sciences
Atlanta, GA
Class II Ongoing
Z-1585-2026 Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The …
Initiated 2026-02-05
Diagnostica Stago, Inc.
Parsippany, NJ
Class II Ongoing
Z-1815-2026 React Health PHOENIX 5L Oxygen Concentrator
Initiated 2026-02-04
3B Medical, Inc.
Dublin, OH
Class II Ongoing
Z-1590-2026 Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8…
Initiated 2026-02-03
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1483-2026 Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product De…
Initiated 2026-02-02
B Braun Medical Inc
Bethlehem, PA
Class II Ongoing
Z-1572-2026 MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Initiated 2026-02-02
Howmedica Osteonics Corp.
Mahwah, NJ
Class II Ongoing
Z-1482-2026 Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A…
Initiated 2026-02-02
B Braun Medical Inc
Bethlehem, PA
Class II Ongoing
Z-1553-2026 CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Initiated 2026-01-30
Beckman Coulter Mishima K.K.
Sunto-Gun, N/A
Class II Ongoing
Z-1562-2026 Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2)…
Initiated 2026-01-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1552-2026 DxC 700 AU, REF: B86444, B86446
Initiated 2026-01-30
Beckman Coulter Mishima K.K.
Sunto-Gun, N/A
Class II Ongoing
Z-1570-2026 Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including…
Initiated 2026-01-30
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1635-2026 MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Initiated 2026-01-30
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1571-2026 Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (inclu…
Initiated 2026-01-30
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1557-2026 HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03…
Initiated 2026-01-30
Covidien LLC
Boulder, CO
Class II Ongoing
Z-0432-2023 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0455-2023 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0431-2023 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-1488-2026 Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be…
Initiated 2026-01-29
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1489-2026 Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to …
Initiated 2026-01-29
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0438-2023 Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0442-2023 Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0428-2023 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0433-2023 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0454-2023 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0453-2023 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0426-2023 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0446-2023 Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0450-2023 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-1655-2026 Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS…
Initiated 2026-01-29
ReCor Medical Inc.
Palo Alto, CA
Class II Ongoing
Z-0436-2023 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0443-2023 Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0439-2023 Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0448-2023 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0437-2023 Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0447-2023 Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-0445-2023 Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
Initiated 2022-10-17
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class I Ongoing
Z-1496-2026 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Initiated 2026-01-27
Becton Dickinson & Company
Franklin Lakes, NJ
Class II Ongoing
Z-1348-2026 Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.…
Initiated 2026-01-26
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-1349-2026 Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - Al…
Initiated 2026-01-26
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-1346-2026 Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R…
Initiated 2026-01-26
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-1350-2026 Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Initiated 2026-01-26
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-1345-2026 Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number -…
Initiated 2026-01-26
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-1344-2026 Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, …
Initiated 2026-01-26
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-1606-2026 HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1605-2026 FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding …
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1597-2026 Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hoo…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1599-2026 I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; …
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1607-2026 HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; A…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1602-2026 Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Corti…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1598-2026 I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forea…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1608-2026 Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding art…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1603-2026 I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Di…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1487-2026 CS300 IABP. Software Version CS300 IABP C.01.
Initiated 2026-01-23
Datascope Corp.
Mahwah, NJ
Class II Ongoing
Z-1486-2026 CS100 IABP. Software Version CS100 IABP Q.01.
Initiated 2026-01-23
Datascope Corp.
Mahwah, NJ
Class II Ongoing
Z-1601-2026 I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1.…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1593-2026 Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavi…
Initiated 2026-01-23
I.T.S. GmbH Class II Ongoing
Z-1383-2026 MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000…
Initiated 2026-01-21
Auris Health, Inc
Santa Clara, CA
Class II Ongoing
Z-1544-2026 PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 0072190…
Initiated 2026-01-21
Physio-Control, Inc.
Redmond, WA
Class II Ongoing
Z-1427-2026 MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 008500…
Initiated 2026-01-21
Stryker Corporation
San Jose, CA
Class II Ongoing
Z-1524-2026 GEM Premier 5000 PAK, Part No. 00055360004.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1533-2026 GEM Premier 5000; Part No. 00055415005.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1539-2026 GEM Premier 5000; Model No. 00055430010.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1538-2026 GEM Premier 5000; Part No. 00055430008.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1534-2026 GEM Premier 5000; Part No. 00055415008.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1531-2026 GEM Premier 5000 PAK; Part No. 00055407511.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1527-2026 GEM Premier 5000 PAK; Part No. 00055360011.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1529-2026 GEM Premier 5000 PAK; Part No. 00055407508.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1542-2026 GEM Premier 5000; Part No. 00055445008.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1530-2026 GEM Premier 5000 PAK; Part No. 00055407510.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1525-2026 GEM Premier 5000 PAK; Part No. 00055360008.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1541-2026 GEM Premier 5000; Part No. 00055445004.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1476-2026 cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464…
Initiated 2026-01-20
Roche Diagnostics Operations, Inc.
Indianapolis, IN
Class II Ongoing
Z-1484-2026 Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Initiated 2026-01-20
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-1535-2026 GEM Premier 5000; Part No. 00055415010.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1537-2026 GEM Premier 5000; Part No. 00055430004.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1536-2026 GEM Premier 5000; Part No: 00055415011.
Initiated 2026-01-20
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1363-2026 MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing wit…
Initiated 2026-01-16
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-1365-2026 Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conduc…
Initiated 2026-01-16
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-1475-2026 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; …
Initiated 2026-01-16
GE Healthcare
Chicago, IL
Class II Ongoing
Z-1364-2026 MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONE…
Initiated 2026-01-16
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-1458-2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Mo…
Initiated 2026-01-15
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-1460-2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/C…
Initiated 2026-01-15
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-1485-2026 Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Vers…
Initiated 2026-01-15
Aesculap Inc
Center Valley, PA
Class II Ongoing
Z-1462-2026 PIE PAK Models: P2HC-A, P2HC-S, P2HC
Initiated 2026-01-14
Edermy LLC
Pendergrass, GA
Class II Ongoing
Z-1473-2026 Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Initiated 2026-01-13
Medtronic Perfusion Systems
Brooklyn Park, MN
Class II Ongoing
Z-1341-2026 Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU…
Initiated 2026-01-13
Laerdal Medical Corporation
Wappingers Falls, NY
Class II Ongoing
Z-1521-2026 Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Initiated 2026-01-12
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-1517-2026 Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Initiated 2026-01-12
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-0143-2023 Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P0…
Initiated 2022-09-30
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-1511-2026 Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Initiated 2026-01-12
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-1520-2026 Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Initiated 2026-01-12
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-0142-2023 Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P0…
Initiated 2022-09-30
Baxter Healthcare Corporation
Deerfield, IL
Class I Ongoing
Z-1512-2026 Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Initiated 2026-01-12
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-1549-2026 Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version…
Initiated 2026-01-09
Medartis AG
Basel Town, N/A
Class II Ongoing
Z-1299-2026 FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Initiated 2026-01-09
FUJIFILM Healthcare Americas Corporation
Lexington, MA
Class II Ongoing
Z-1464-2026 Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Initiated 2026-01-08
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1468-2026 Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Initiated 2026-01-08
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1465-2026 Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LI…
Initiated 2026-01-08
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1463-2026 Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU C…
Initiated 2026-01-08
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1467-2026 Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESS…
Initiated 2026-01-08
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1290-2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instr…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1287-2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These ins…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1392-2026 Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1407-2026 Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1271-2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1315-2026 Brilliance iCT; Product Code (REF): 728306;
Initiated 2026-01-07
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1273-2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1401-2026 Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DY…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1406-2026 Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1317-2026 Spectral CT; Product Code (REF): 728333;
Initiated 2026-01-07
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1402-2026 Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Numb…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1410-2026 Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1289-2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1296-2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instr…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1419-2026 Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Mode…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1270-2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These ins…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1288-2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These ins…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1297-2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software …
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1286-2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1278-2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software …
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1395-2026 Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1275-2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1405-2026 Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1385-2026 Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: D…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1394-2026 Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1398-2026 Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1277-2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1408-2026 Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1285-2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These ins…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1411-2026 Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1268-2026 Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1284-2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software V…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1384-2026 Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Num…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1403-2026 Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1415-2026 Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS98…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1316-2026 IQon Spectral CT; Product Code (REF): 728332;
Initiated 2026-01-07
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1404-2026 Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1396-2026 Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1274-2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1397-2026 Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Nu…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1280-2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software …
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1413-2026 Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1279-2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software …
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1388-2026 Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: D…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1424-2026 Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1292-2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instr…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1414-2026 Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1400-2026 Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Mode…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1425-2026 Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1391-2026 Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Numbe…
Initiated 2026-01-07
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1295-2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instr…
Initiated 2026-01-07
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1227-2026 PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Initiated 2026-01-06
VANTIVE US HEALTHCARE LLC
Deerfield, IL
Class II Ongoing
Z-1224-2026 PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Initiated 2026-01-06
VANTIVE US HEALTHCARE LLC
Deerfield, IL
Class II Ongoing
Z-1226-2026 OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Initiated 2026-01-06
VANTIVE US HEALTHCARE LLC
Deerfield, IL
Class II Ongoing
Z-1228-2026 PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Initiated 2026-01-06
VANTIVE US HEALTHCARE LLC
Deerfield, IL
Class II Ongoing
Z-1231-2026 PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Initiated 2026-01-06
VANTIVE US HEALTHCARE LLC
Deerfield, IL
Class II Ongoing
Z-1229-2026 PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Initiated 2026-01-06
VANTIVE US HEALTHCARE LLC
Deerfield, IL
Class II Ongoing
Z-1225-2026 PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Initiated 2026-01-06
VANTIVE US HEALTHCARE LLC
Deerfield, IL
Class II Ongoing
Z-1236-2026 VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem…
Initiated 2026-01-05
Biomerieux Inc
Hazelwood, MO
Class II Ongoing
Z-1498-2026 Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (At…
Initiated 2026-01-05
Raz Design Inc
North York, N/A
Class II Ongoing
Z-1434-2026 Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Initiated 2026-01-05
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1435-2026 Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,…
Initiated 2026-01-05
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1338-2026 Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Initiated 2026-01-02
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-1343-2026 ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471;…
Initiated 2026-01-02
Alphatec Spine, Inc.
Carlsbad, CA
Class II Ongoing
Z-1366-2026 Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYN…
Initiated 2025-12-31
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1220-2026 BEAR Implant. Model Number: 1000.
Initiated 2025-12-31
Miach Orthopaedics
Westborough, MA
Class II Ongoing
Z-1355-2026 da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Initiated 2025-12-30
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-1174-2026 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Ve…
Initiated 2025-12-29
Siemens Medical Solutions USA, Inc
Malvern, PA
Class II Ongoing
Z-1165-2026 PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Initiated 2025-12-29
Cerapedics, Inc.
Westminster, CO
Class II Ongoing
Z-1203-2026 Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2.…
Initiated 2025-12-26
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-1182-2026 Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS T…
Initiated 2025-12-26
GOLD STAR DISTRIBUTION INC
Minneapolis, MN
Class II Ongoing
Z-1183-2026 Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W B…
Initiated 2025-12-26
GOLD STAR DISTRIBUTION INC
Minneapolis, MN
Class II Ongoing
Z-1331-2026 Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE…
Initiated 2025-12-24
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1312-2026 Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Initiated 2025-12-24
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1328-2026 Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Initiated 2025-12-24
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1112-2026 GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen…
Initiated 2025-12-24
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Class II Ongoing
Z-1243-2026 Focalyx Fusion
Initiated 2025-12-23
Focalyx Technologies, LLC.
Hialeah, FL
Class II Ongoing
Z-1219-2026 LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Initiated 2025-12-22
LSL Healthcare Inc.
Niles, IL
Class II Ongoing
Z-1017-2026 VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Initiated 2025-12-19
Canon Medical System, USA, INC.
Tustin, CA
Class II Ongoing
Z-1111-2026 Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Initiated 2025-12-19
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-1132-2026 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Mo…
Initiated 2025-12-19
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1177-2026 Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Initiated 2025-12-19
Canon Medical System, USA, INC.
Tustin, CA
Class II Ongoing
Z-1242-2026 NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPE…
Initiated 2025-12-19
Siemens Medical Solutions USA, Inc
Malvern, PA
Class II Ongoing
Z-1239-2026 SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Initiated 2025-12-19
Siemens Medical Solutions USA, Inc
Malvern, PA
Class II Ongoing
Z-1100-2026 Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Initiated 2025-12-19
ICU Medical Inc.
Minneapolis, MN
Class II Ongoing
Z-1018-2026 VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Initiated 2025-12-19
Canon Medical System, USA, INC.
Tustin, CA
Class II Ongoing
Z-1560-2026 Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Initiated 2025-12-19
Altruan GmbH
Massing, N/A
Class II Ongoing
Z-1137-2026 Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a s…
Initiated 2025-12-18
Community Products, LLC
Rifton, NY
Class II Ongoing
Z-1139-2026 Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjus…
Initiated 2025-12-18
Community Products, LLC
Rifton, NY
Class II Ongoing
Z-1173-2026 AlternatiV+ Screw-In Anchor
Initiated 2025-12-17
Aju Pharm Co., Ltd.
Seongnam, N/A
Class II Ongoing
Z-1171-2026 Genesis Push-In Suture Anchor
Initiated 2025-12-17
Aju Pharm Co., Ltd.
Seongnam, N/A
Class II Ongoing
Z-1167-2026 Fixone Biocomposite Anchor
Initiated 2025-12-17
Aju Pharm Co., Ltd.
Seongnam, N/A
Class II Ongoing
Z-1166-2026 Fixone Hybrid Anchor
Initiated 2025-12-17
Aju Pharm Co., Ltd.
Seongnam, N/A
Class II Ongoing
Z-1170-2026 Genesis Knotless Anchor
Initiated 2025-12-17
Aju Pharm Co., Ltd.
Seongnam, N/A
Class II Ongoing
Z-1172-2026 AlternatiV+ Max Knotless Anchor
Initiated 2025-12-17
Aju Pharm Co., Ltd.
Seongnam, N/A
Class II Ongoing
Z-1249-2026 Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25…
Initiated 2025-12-16
Vortex Surgical Inc.
Saint Charles, MO
Class II Ongoing
Z-1090-2026 Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Initiated 2025-12-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1089-2026 Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY C…
Initiated 2025-12-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1245-2026 Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. …
Initiated 2025-12-16
Vortex Surgical Inc.
Saint Charles, MO
Class II Ongoing
Z-1254-2026 Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Initiated 2025-12-16
Vortex Surgical Inc.
Saint Charles, MO
Class II Ongoing
Z-1252-2026 Vortex Surgical I2 Injection Kit, VS0500
Initiated 2025-12-16
Vortex Surgical Inc.
Saint Charles, MO
Class II Ongoing
Z-1255-2026 Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Initiated 2025-12-16
Vortex Surgical Inc.
Saint Charles, MO
Class II Ongoing
Z-1086-2026 Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOP…
Initiated 2025-12-16
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1246-2026 Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Las…
Initiated 2025-12-16
Vortex Surgical Inc.
Saint Charles, MO
Class II Ongoing
Z-1369-2026 Estrone RIA, REF: DSL8700
Initiated 2025-12-15
Immunotech A.S. Class II Ongoing
Z-1096-2026 da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1…
Initiated 2025-12-15
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-1063-2026 Allura Xper FD10F; Model Number: 722002;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1074-2026 Allura Xper FD10/10; Model Number: 722027;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1075-2026 Allura Xper FD20; Model Number: 722028;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1062-2026 Product Name: Allura Xper FD10C; Model number: 722001;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1064-2026 Allura Xper FD10; Model Number: 722003;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1118-2026 ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Initiated 2025-12-15
ICU Medical, Inc.
Lake Forest, IL
Class II Ongoing
Z-1120-2026 ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Initiated 2025-12-15
ICU Medical, Inc.
Lake Forest, IL
Class II Ongoing
Z-1069-2026 Allura Xper FD10/10; Model Number: 722011;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1077-2026 Allura Xper FD20/20; Model Number: 722038;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1065-2026 Allura Xper FD10/10; Model Number: 722005;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1070-2026 Allura Xper FD20; Model Number: 722012;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1084-2026 Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection i…
Initiated 2025-12-15
Diagnostica Stago, Inc.
Parsippany, NJ
Class II Ongoing
Z-1076-2026 Allura Xper FD20/10; Model Number: 722029;
Initiated 2025-12-15
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1119-2026 ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Initiated 2025-12-15
ICU Medical, Inc.
Lake Forest, IL
Class II Ongoing
Z-1036-2026 Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when di…
Initiated 2025-12-12
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-1200-2026 Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE …
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1340-2026 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr…
Initiated 2025-12-12
Elekta, Inc.
Atlanta, GA
Class II Ongoing
Z-1186-2026 Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1367-2026 Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Initiated 2025-12-12
Bard Peripheral Vascular Inc
Tempe, AZ
Class II Ongoing
Z-1189-2026 Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST …
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1191-2026 Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDO…
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1195-2026 Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC …
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1194-2026 Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1193-2026 Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU…
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1199-2026 Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK…
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1187-2026 Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP R…
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1093-2026 ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Initiated 2025-12-12
Hologic, Inc
Marlborough, MA
Class II Ongoing
Z-1196-2026 Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR…
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1197-2026 Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELV…
Initiated 2025-12-12
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1091-2026 Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres…
Initiated 2025-12-12
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1304-2026 Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product…
Initiated 2025-12-11
Fujirebio Diagnostics, Inc.
Malvern, PA
Class II Ongoing
Z-1303-2026 Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Pr…
Initiated 2025-12-11
Fujirebio Diagnostics, Inc.
Malvern, PA
Class II Ongoing
Z-1301-2026 Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Appli…
Initiated 2025-12-11
Fujirebio Diagnostics, Inc.
Malvern, PA
Class II Ongoing
Z-1307-2026 Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Produc…
Initiated 2025-12-11
Fujirebio Diagnostics, Inc.
Malvern, PA
Class II Ongoing
Z-1078-2026 MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Initiated 2025-12-10
Elekta, Inc.
Atlanta, GA
Class II Ongoing
Z-1701-2026 Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instru…
Initiated 2025-12-09
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-1698-2026 Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Mo…
Initiated 2025-12-09
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-1699-2026 Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Mo…
Initiated 2025-12-09
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-1696-2026 Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scisso…
Initiated 2025-12-09
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-1654-2022 Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro…
Initiated 2022-08-26
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1079-2026 Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M…
Initiated 2025-12-08
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1656-2022 Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea s…
Initiated 2022-08-26
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1658-2022 Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstru…
Initiated 2022-08-26
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1659-2022 Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patient…
Initiated 2022-08-26
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1034-2026 Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000,…
Initiated 2025-12-08
IMRIS Imaging Inc
Chaska, MN
Class II Ongoing
Z-1008-2026 BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Initiated 2025-12-05
Beaver-Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-1019-2026 Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Initiated 2025-12-05
Meridian Bioscience Inc
Cincinnati, OH
Class II Ongoing
Z-1124-2026 Allwell Inflation Device, for angiographic use REF: IS-30-A
Initiated 2025-12-04
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-1123-2026 Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130…
Initiated 2025-12-04
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-1127-2026 Merit Medical , Custom Manifold Kit REF: K09-13203A
Initiated 2025-12-04
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-1040-2026 Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Initiated 2025-12-04
Mobius Imaging, LLC
Shirley, MA
Class II Ongoing
Z-1125-2026 Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Initiated 2025-12-04
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-1126-2026 Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05…
Initiated 2025-12-04
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-1215-2026 SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1209-2026 Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1028-2026 BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, …
Initiated 2025-12-03
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-1043-2026 A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software …
Initiated 2025-12-03
Medtronic Neuromodulation
Minneapolis, MN
Class II Ongoing
Z-1204-2026 Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1207-2026 Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1213-2026 MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1208-2026 Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1212-2026 Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.…
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1205-2026 Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1216-2026 SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1210-2026 Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.…
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1211-2026 Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1…
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-1214-2026 Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Initiated 2025-12-03
Philips North America
Cambridge, MA
Class II Ongoing
Z-0972-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0970-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0975-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0984-2026 KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Initiated 2025-12-02
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-0968-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0982-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0974-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0971-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0969-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0980-2026 Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
Initiated 2025-12-02
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0985-2026 KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Initiated 2025-12-02
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-0986-2026 LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Initiated 2025-12-02
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-1061-2026 BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Initiated 2025-11-29
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. Class II Ongoing
Z-1121-2026 SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Initiated 2025-11-28
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1054-2026 Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL P…
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1055-2026 Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPP…
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1025-2026 Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Initiated 2025-11-26
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-1026-2026 Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Initiated 2025-11-26
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-1057-2026 Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medl…
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1051-2026 Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KI…
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1049-2026 Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH K…
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1027-2026 Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel …
Initiated 2025-11-26
Remote Diagnostic Technologies Ltd. Class II Ongoing
Z-1058-2026 Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medl…
Initiated 2025-11-26
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1005-2026 Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description:…
Initiated 2025-11-25
Ferndale Laboratories, Inc.
Ferndale, MI
Class II Ongoing
Z-0957-2026 BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Initiated 2025-11-24
Smith & Nephew, Inc.
Mansfield, MA
Class II Ongoing
Z-0965-2026 LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Initiated 2025-11-24
ICU Medical, Inc.
Lake Forest, IL
Class II Ongoing
Z-0966-2026 LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Initiated 2025-11-24
ICU Medical, Inc.
Lake Forest, IL
Class II Ongoing
Z-1262-2026 Male Fertility Sperm Test for Home Use (Cassette)
Initiated 2025-11-22
Changchun Wancheng Bio-Electron Co., Ltd.
Changchun, N/A
Class II Ongoing
Z-1263-2026 Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Initiated 2025-11-22
Changchun Wancheng Bio-Electron Co., Ltd.
Changchun, N/A
Class II Ongoing
Z-1265-2026 Vivoo Protein Test
Initiated 2025-11-22
Changchun Wancheng Bio-Electron Co., Ltd.
Changchun, N/A
Class II Ongoing
Z-1257-2026 LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in…
Initiated 2025-11-22
Changchun Wancheng Bio-Electron Co., Ltd.
Changchun, N/A
Class II Ongoing
Z-1261-2026 S. Typhi/Para Typhi A Antigen
Initiated 2025-11-22
Changchun Wancheng Bio-Electron Co., Ltd.
Changchun, N/A
Class II Ongoing
Z-0323-2023 Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Initiated 2022-08-09
DEWEI MEDICAL EQUIPMENT CO LTD
Foshan, N/A
Class I Ongoing
Z-1035-2026 Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK…
Initiated 2025-11-21
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-1048-2026 Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Initiated 2025-11-21
Fresenius Kabi USA, LLC
North Andover, MA
Class II Ongoing
Z-0962-2026 BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower…
Initiated 2025-11-20
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-0996-2026 Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90…
Initiated 2025-11-20
Medtronic Neuromodulation
Minneapolis, MN
Class II Ongoing
Z-0909-2026 AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfect…
Initiated 2025-11-19
Steris Corporation
Mentor, OH
Class II Ongoing
Z-0910-2026 AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfec…
Initiated 2025-11-19
Steris Corporation
Mentor, OH
Class II Ongoing
Z-0920-2026 Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring …
Initiated 2025-11-18
Mindray DS USA, Inc. dba Mindray North America
Mahwah, NJ
Class II Ongoing
Z-0923-2026 Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Initiated 2025-11-18
AGFA Healthcare Corp.
Greenville, SC
Class II Ongoing
Z-1311-2026 Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,…
Initiated 2025-11-17
ETAC A/S
Gedved, N/A
Class II Ongoing
Z-1029-2026 The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Initiated 2025-11-17
Sophysa Class II Ongoing
Z-1308-2026 Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, …
Initiated 2025-11-17
ETAC A/S
Gedved, N/A
Class II Ongoing
Z-1479-2026 Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog …
Initiated 2025-11-14
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0961-2026 Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Initiated 2025-11-13
Abbott Laboratories
Irving, TX
Class II Ongoing
Z-0963-2026 The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infr…
Initiated 2025-11-12
Howmedica Osteonics Corp.
Mahwah, NJ
Class II Ongoing
Z-0897-2026 ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-…
Initiated 2025-11-12
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-1454-2026 Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1442-2026 Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applicatio…
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1450-2026 Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1445-2026 Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1455-2026 Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1446-2026 Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatio…
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1447-2026 Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1439-2026 Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1444-2026 Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic application…
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1448-2026 Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1452-2026 Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1449-2026 Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1440-2026 Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1457-2026 Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1453-2026 Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Initiated 2025-11-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1221-2026 COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjun…
Initiated 2025-11-10
Beckman Coulter, Inc.
Miami, FL
Class II Ongoing
Z-0889-2026 Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio…
Initiated 2025-11-07
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-0907-2026 BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Initiated 2025-11-06
C.R. Bard Inc
Covington, GA
Class II Ongoing
Z-0905-2026 Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Initiated 2025-11-06
C.R. Bard Inc
Covington, GA
Class II Ongoing
Z-0906-2026 BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Initiated 2025-11-06
C.R. Bard Inc
Covington, GA
Class II Ongoing
Z-0724-2026 Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Initiated 2025-11-05
Cepheid
Sunnyvale, CA
Class II Ongoing
Z-0992-2026 Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C…
Initiated 2025-11-05
Diasol, Inc
Phoenix, AZ
Class II Ongoing
Z-0987-2026 Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C…
Initiated 2025-11-05
Diasol, Inc
Phoenix, AZ
Class II Ongoing
Z-0989-2026 Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C…
Initiated 2025-11-05
Diasol, Inc
Phoenix, AZ
Class II Ongoing
Z-0917-2026 Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Initiated 2025-11-04
Datascope Corp.
Mahwah, NJ
Class II Ongoing
Z-0916-2026 Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Initiated 2025-11-04
Datascope Corp.
Mahwah, NJ
Class II Ongoing
Z-0808-2026 Food Intolerance Test Small
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0756-2026 Vitamin D-Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0775-2026 Candida Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0767-2026 Organic Acids Profile Test Large
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0769-2026 Allergy Test IgE
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0804-2026 Allergy test Small
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0764-2026 GI Microbiome Profile XL
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0733-2026 Illegally Marketed
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0741-2026 HPV Antigen Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0750-2026 Sperm Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0746-2026 Mycoplasma test, IgG and IgM
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0793-2026 Parasite Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0772-2026 Adrenal Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0790-2026 Neurotransmitters Plus
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0814-2026 Pollen Allergy Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0848-2026 Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Initiated 2025-11-03
Fresenius Kabi USA, LLC
North Andover, MA
Class II Ongoing
Z-0727-2026 Alcohol (ALC) Test Saliva
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0782-2026 Gut Microbiome Test XL
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0813-2026 Pet Allergy Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0754-2026 Urinary Tract Infection Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0786-2026 Lactose Intolerance Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0795-2026 PSA Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0781-2026 Gut Microbiome Test Small
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0818-2026 8 in 1 STI Test Kit
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0773-2026 Akkermansia Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0807-2026 Food Intolerance Test Medium
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0760-2026 Food Sensitivity Test Large
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0765-2026 Mycotoxin Panel Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0762-2026 Food Sensitivity Test Small
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0803-2026 Allergy test Small
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0794-2026 Peptic Ulcer Test (H, pylori)
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0809-2026 Heavy Metals Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0777-2026 Fructose Intolerance Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0753-2026 Trichomonas Vaginalis test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0796-2026 SIBO Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0785-2026 Intestinal Worms Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0731-2026 D-Dimer Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0732-2026 Diabetes HbA1c Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0729-2026 Candida Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0751-2026 Syphilis Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0810-2026 Iodine Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0745-2026 MPOX Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0763-2026 GI Microbiome Profile Small
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0748-2026 Parasite Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0757-2026 Sperm Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0776-2026 DHEA Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0815-2026 Serotonin Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0737-2026 Female Fertility Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0780-2026 Gut Microbiome Test Mega
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0759-2026 Food Allergy Panel Test (IgE)
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0806-2026 Food Intolerance Test Large
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0766-2026 NAD Profile Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0768-2026 Vitamin D2 and D3 Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0787-2026 Leaky Gut Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0800-2026 Kidney Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0816-2026 2 in 1 Trichomonas / Gardnerella Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0744-2026 Menopause (FSH) 2 Tests
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0728-2026 Blood Type Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0817-2026 3 in 1 STI Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0774-2026 Biological Age & Longevity Test
Initiated 2025-11-03
GET TESTED INTERNATIONAL AB Class II Ongoing
Z-0858-2026 IntelliVue MP90. Product Number: M8010A.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0852-2026 IntelliVue MP30. Product Number: M8002A.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0869-2026 IntelliVue Patient Monitor MX800. Product Number: 865240.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0883-2026 Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Initiated 2025-10-31
Philips Ultrasound, LLC
Bothell, WA
Class II Ongoing
Z-0867-2026 IntelliVue Patient Monitor MX700. Product Number: 865241.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0864-2026 IntelliVue Patient Monitor MX500. Product Number: 866064.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0870-2026 IntelliVue Patient Monitor MX850. Product Number: 866470.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0601-2026 NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shep…
Initiated 2025-10-31
Stryker Corporation
Portage, MI
Class II Ongoing
Z-0599-2026 NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP …
Initiated 2025-10-31
Stryker Corporation
Portage, MI
Class II Ongoing
Z-0849-2026 IntelliVue MP2. Product Number: M8102A.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0854-2026 IntelliVue MP50. Product Number: M8004A.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0857-2026 IntelliVue MP80. Product Number: M8008A.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0861-2026 IntelliVue Patient Monitor MX100. Product Number: 867033.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0853-2026 IntelliVue MP40. Product Number: M8003A.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0872-2026 Olympus OER-Elite
Initiated 2025-10-31
Aizu Olympus Co., Ltd. Class II Ongoing
Z-0859-2026 IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0855-2026 IntelliVue MP60. Product Number: M8005A.
Initiated 2025-10-31
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1039-2026 Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Initiated 2025-10-29
Medicrea International Class II Ongoing
Z-0882-2026 CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Initiated 2025-10-29
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0881-2026 Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Initiated 2025-10-29
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0726-2026 Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product …
Initiated 2025-10-29
Medtronic, Inc.
Mounds View, MN
Class II Ongoing
Z-0847-2026 Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn T…
Initiated 2025-10-28
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1140-2026 Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedsid…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-1142-2026 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Moni…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-1151-2026 Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Descript…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-1153-2026 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Mon…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-0878-2026 MAMMOMAT Inspiration;
Initiated 2025-10-24
Siemens Medical Solutions USA, Inc
Malvern, PA
Class II Ongoing
Z-1155-2026 Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects ph…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-0879-2026 MAMMOMAT Fusion;
Initiated 2025-10-24
Siemens Medical Solutions USA, Inc
Malvern, PA
Class II Ongoing
Z-1149-2026 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX ser…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-1146-2026 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-1154-2026 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series …
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-1143-2026 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three w…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-1152-2026 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Mon…
Initiated 2025-10-24
Edan Diagnostics
San Diego, CA
Class II Ongoing
Z-1371-2026 Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Initiated 2025-10-22
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1378-2026 Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Initiated 2025-10-22
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1373-2026 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Initiated 2025-10-22
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1381-2026 Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Initiated 2025-10-22
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1375-2026 Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Initiated 2025-10-22
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1377-2026 Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Initiated 2025-10-22
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1382-2026 Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Initiated 2025-10-22
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0594-2026 CareLink Clinic, REF: MMT-7350
Initiated 2025-10-21
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-0720-2026 Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (S…
Initiated 2025-10-20
Mindray DS USA, Inc. dba Mindray North America
Mahwah, NJ
Class II Ongoing
Z-0539-2026 Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Initiated 2025-10-20
Medtronic Perfusion Systems
Brooklyn Park, MN
Class II Ongoing
Z-0721-2026 Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Sa…
Initiated 2025-10-20
Mindray DS USA, Inc. dba Mindray North America
Mahwah, NJ
Class II Ongoing
Z-0423-2026 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm…
Initiated 2025-10-17
Mozarc Medical US LLC
Mansfield, MA
Class II Ongoing
Z-0424-2026 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 …
Initiated 2025-10-17
Mozarc Medical US LLC
Mansfield, MA
Class II Ongoing
Z-0582-2026 Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Initiated 2025-10-17
Straumann USA LLC
Andover, MA
Class II Ongoing
Z-0421-2026 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm…
Initiated 2025-10-17
Mozarc Medical US LLC
Mansfield, MA
Class II Ongoing
Z-0422-2026 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm…
Initiated 2025-10-17
Mozarc Medical US LLC
Mansfield, MA
Class II Ongoing
Z-0504-2026 BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Initiated 2025-10-14
Becton Dickinson & Company
Franklin Lakes, NJ
Class II Ongoing
Z-0871-2026 Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Initiated 2025-10-13
Paragon 28, Inc.
Englewood, CO
Class II Ongoing
Z-1436-2026 MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with…
Initiated 2025-10-13
MRIMed Inc.
Petaluma, CA
Class II Ongoing
Z-0956-2026 Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouth…
Initiated 2025-10-09
Myofunctional Research Company USA
Rancho Cucamonga, CA
Class II Ongoing
Z-0506-2026 Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Co…
Initiated 2025-10-09
Thoratec LLC
Pleasanton, CA
Class II Ongoing
Z-0436-2026 Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
Initiated 2025-10-09
B-K Medical A/S
Herlev, N/A
Class II Ongoing
Z-0440-2026 bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
Initiated 2025-10-09
B-K Medical A/S
Herlev, N/A
Class II Ongoing
Z-0437-2026 UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
Initiated 2025-10-09
B-K Medical A/S
Herlev, N/A
Class II Ongoing
Z-0508-2026 Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ …
Initiated 2025-10-09
Thoratec LLC
Pleasanton, CA
Class II Ongoing
Z-0507-2026 Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Ki…
Initiated 2025-10-09
Thoratec LLC
Pleasanton, CA
Class II Ongoing
Z-0587-2026 Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Initiated 2025-10-09
Pivotal Health Solutions, Inc.
Watertown, SD
Class II Ongoing
Z-0435-2026 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focu…
Initiated 2025-10-09
B-K Medical A/S
Herlev, N/A
Class II Ongoing
Z-0438-2026 bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Initiated 2025-10-09
B-K Medical A/S
Herlev, N/A
Class II Ongoing
Z-0452-2026 Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Prod…
Initiated 2025-10-08
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0542-2026 REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest…
Initiated 2025-10-08
Cellavision AB Class II Ongoing
Z-0481-2026 SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th…
Initiated 2025-10-07
Philips Respironics, Inc.
Murrysville, PA
Class II Ongoing
Z-0413-2026 Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Initiated 2025-10-07
Trividia Health, Inc.
Ft Lauderdale, FL
Class II Ongoing
Z-0493-2026 Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Initiated 2025-10-06
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-0483-2026 Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgi…
Initiated 2025-10-06
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0492-2026 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci…
Initiated 2025-10-06
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-0491-2026 IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Initiated 2025-10-06
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-1489-2022 Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model …
Initiated 2022-06-22
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1485-2022 Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC…
Initiated 2022-06-22
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1486-2022 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, M…
Initiated 2022-06-22
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-0509-2026 MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Initiated 2025-10-03
Medtronic Perfusion Systems
Brooklyn Park, MN
Class II Ongoing
Z-0466-2026 Radiography 7300 C; Model Number: 712037;
Initiated 2025-10-01
Philips Medical Systems DMC GmbH Class II Ongoing
Z-0471-2026 Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15…
Initiated 2025-10-01
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0469-2026 Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 …
Initiated 2025-10-01
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0465-2026 DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
Initiated 2025-10-01
Philips Medical Systems DMC GmbH Class II Ongoing
Z-0317-2026 Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magneti…
Initiated 2025-10-01
ENDOMAGNETICS LTD
Cambridge, N/A
Class II Ongoing
Z-0470-2026 Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.…
Initiated 2025-10-01
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0474-2026 Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.…
Initiated 2025-10-01
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0463-2026 Precision CRF; Model Number: 706400;
Initiated 2025-10-01
Philips Medical Systems DMC GmbH Class II Ongoing
Z-0477-2026 Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.…
Initiated 2025-10-01
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0473-2026 Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1…
Initiated 2025-10-01
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0461-2026 ProxiDiagnost N90; Model Number: 706110;
Initiated 2025-10-01
Philips Medical Systems DMC GmbH Class II Ongoing
Z-0472-2026 Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.…
Initiated 2025-10-01
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0519-2026 MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3)…
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0525-2026 MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0529-2026 MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0514-2026 MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0370-2026 BD Pyxis Pro MedStation Main, REF: 1155-00
Initiated 2025-09-30
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-0528-2026 MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0524-2026 MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF …
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0368-2026 Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 13…
Initiated 2025-09-30
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-0523-2026 MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, …
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0526-2026 MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-S…
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0512-2026 MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0369-2026 Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Initiated 2025-09-30
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-0511-2026 MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0517-2026 MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS86001…
Initiated 2025-09-30
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0564-2026 SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product D…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0545-2026 SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/C…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0544-2026 SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 610…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0556-2026 SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product …
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0547-2026 SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 …
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0455-2026 B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-1…
Initiated 2025-09-26
GE Healthcare Finland Oy Class II Ongoing
Z-0454-2026 CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a …
Initiated 2025-09-26
GE Healthcare Finland Oy Class II Ongoing
Z-0562-2026 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 P…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0558-2026 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 …
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0553-2026 SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0550-2026 SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Mod…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0561-2026 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Pr…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0566-2026 Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0552-2026 SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 725…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0559-2026 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, …
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0456-2026 Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Initiated 2025-09-26
GE Healthcare Finland Oy Class II Ongoing
Z-0228-2026 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Ret…
Initiated 2025-09-26
Synthes (USA) Products LLC
West Chester, PA
Class II Ongoing
Z-0548-2026 SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 …
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0555-2026 SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0565-2026 SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0554-2026 SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog …
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0457-2026 BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Pa…
Initiated 2025-09-26
GE Healthcare Finland Oy Class II Ongoing
Z-0546-2026 SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/C…
Initiated 2025-09-26
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-0486-2026 Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06…
Initiated 2025-09-25
Covidien, LP
North Haven, CT
Class II Ongoing
Z-0485-2026 Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Initiated 2025-09-25
Covidien, LP
North Haven, CT
Class II Ongoing
Z-0722-2026 Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Initiated 2025-09-25
DJO, LLC
Carlsbad, CA
Class II Ongoing
Z-0309-2026 Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Ver…
Initiated 2025-09-24
Aesculap Inc
Center Valley, PA
Class II Ongoing
Z-0312-2026 Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N…
Initiated 2025-09-24
Aesculap Inc
Center Valley, PA
Class II Ongoing
Z-0235-2026 BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog…
Initiated 2025-09-23
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0237-2026 BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. …
Initiated 2025-09-23
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0432-2026 Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 320…
Initiated 2025-09-23
Total Joint Orthopedics, Inc.
Salt Lake City, UT
Class II Ongoing
Z-0541-2026 DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for us…
Initiated 2025-09-22
Beckman Coulter Inc.
Brea, CA
Class II Ongoing
Z-0145-2026 Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Soft…
Initiated 2025-09-19
Kico Knee Innovation Company Class II Ongoing
Z-0216-2026 DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Initiated 2025-09-19
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-0208-2026 Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque …
Initiated 2025-09-18
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0156-2026 LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Initiated 2025-09-18
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-0116-2026 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a…
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0207-2026 Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264…
Initiated 2025-09-18
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0211-2026 Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x…
Initiated 2025-09-18
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0125-2026 Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga.…
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0123-2026 Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x…
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0115-2026 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged an…
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0122-2026 ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN …
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0209-2026 Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem …
Initiated 2025-09-18
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0114-2026 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and …
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0489-2026 Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.…
Initiated 2025-09-18
Abbott Laboratories
Santa Clara, CA
Class II Ongoing
Z-0158-2026 Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Initiated 2025-09-18
Fisher & Paykel Healthcare, Ltd. Class II Ongoing
Z-0126-2026 Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD J…
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0157-2026 LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Initiated 2025-09-18
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-0120-2026 PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1…
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0124-2026 Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY.…
Initiated 2025-09-18
B BRAUN MEDICAL INC
Allentown, PA
Class II Ongoing
Z-0233-2026 Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 0169…
Initiated 2025-09-17
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0230-2026 Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS20…
Initiated 2025-09-17
CPM Medical Consultants, LLC.
Farmers Branch, TX
Class II Ongoing
Z-0725-2026 InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 9001…
Initiated 2025-09-17
Enterix, Inc.
Edison, NJ
Class II Ongoing
Z-0319-2026 SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Initiated 2025-09-16
Surgical Theater Inc
Beachwood, OH
Class II Ongoing
Z-0325-2026 Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Initiated 2025-09-16
Surgical Theater Inc
Beachwood, OH
Class II Ongoing
Z-0323-2026 Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processin…
Initiated 2025-09-16
Surgical Theater Inc
Beachwood, OH
Class II Ongoing
Z-0324-2026 SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic a…
Initiated 2025-09-16
Surgical Theater Inc
Beachwood, OH
Class II Ongoing
Z-0320-2026 Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Initiated 2025-09-16
Surgical Theater Inc
Beachwood, OH
Class II Ongoing
Z-0321-2026 Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radi…
Initiated 2025-09-16
Surgical Theater Inc
Beachwood, OH
Class II Ongoing
Z-0581-2026 CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 806…
Initiated 2025-09-15
Alcon Research LLC
Fort Worth, TX
Class II Ongoing
Z-0165-2026 Cardiac Workstation 5000; Model Number: 860439;
Initiated 2025-09-12
Philips North America
Cambridge, MA
Class II Ongoing
Z-0589-2026 Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicate…
Initiated 2025-09-12
Argon Medical Devices, Inc
Athens, TX
Class II Ongoing
Z-0205-2026 Product: STA Liatest D-Di; REF: 00515;
Initiated 2025-09-12
Diagnostica Stago, Inc.
Parsippany, NJ
Class II Ongoing
Z-0234-2026 Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syri…
Initiated 2025-09-11
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-0133-2026 FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
Initiated 2025-09-11
Ferno-Washington Inc
Wilmington, OH
Class II Ongoing
Z-0139-2026 TENACIO Pump without InhibiZone; UPN: 72404420;
Initiated 2025-09-11
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-0227-2026 iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-…
Initiated 2025-09-11
Theken Companies LLC
Akron, OH
Class II Ongoing
Z-0138-2026 TENACIO Pump with InhibiZone; UPN: 72404429;
Initiated 2025-09-11
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-0141-2026 LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Initiated 2025-09-11
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-2673-2025 Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type…
Initiated 2025-09-09
MedicalCommunications GmbH
Heidelberg, N/A
Class II Ongoing
Z-2619-2025 Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
Initiated 2025-09-09
Biomet, Inc.
Warsaw, IN
Class II Ongoing
Z-0348-2026 ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0357-2026 ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0330-2026 ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0364-2026 ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0356-2026 ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0354-2026 ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0329-2026 ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0351-2026 ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0353-2026 ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0332-2026 ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re…
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0365-2026 ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0412-2026 CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU…
Initiated 2025-09-08
Beckman Coulter, Inc.
Miami, FL
Class II Ongoing
Z-0337-2026 ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0333-2026 ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, …
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0347-2026 ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0352-2026 ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0331-2026 ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0350-2026 ICU Medical ChemoLock Port REF: CL2100
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0362-2026 ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/Chem…
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0342-2026 ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0363-2026 ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0338-2026 ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/Che…
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0341-2026 ICU Medical ChemoLock Bag Spike REF: CL-10
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0336-2026 ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0346-2026 ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0358-2026 ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0359-2026 ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger…
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0349-2026 ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0361-2026 ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Initiated 2025-09-08
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0135-2026 C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microi…
Initiated 2025-09-06
Iantrek Inc.
Providence, RI
Class II Ongoing
Z-0134-2026 Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinter…
Initiated 2025-09-06
Iantrek Inc.
Providence, RI
Class II Ongoing
Z-0068-2026 AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Initiated 2025-09-05
GE Medical Systems, SCS Class II Ongoing
Z-0169-2026 Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-0…
Initiated 2025-09-05
Spacelabs Healthcare, Inc.
Snoqualmie, WA
Class II Ongoing
Z-0168-2026 Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-1…
Initiated 2025-09-05
Spacelabs Healthcare, Inc.
Snoqualmie, WA
Class II Ongoing
Z-0180-2026 Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN…
Initiated 2025-09-04
American Contract Systems Inc.
Grimes, IA
Class II Ongoing
Z-0185-2026 Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17…
Initiated 2025-09-04
American Contract Systems Inc.
Grimes, IA
Class II Ongoing
Z-0174-2026 Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC…
Initiated 2025-09-04
American Contract Systems Inc.
Grimes, IA
Class II Ongoing
Z-0173-2026 Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL…
Initiated 2025-09-04
American Contract Systems Inc.
Grimes, IA
Class II Ongoing
Z-0187-2026 Medical convenience kits IHDC30R D AND C PACK
Initiated 2025-09-04
American Contract Systems Inc.
Grimes, IA
Class II Ongoing
Z-0170-2026 Basic Biopsy Tray, Item Number NMBP44L
Initiated 2025-09-04
American Contract Systems Inc.
Grimes, IA
Class II Ongoing
Z-0184-2026 Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15…
Initiated 2025-09-04
American Contract Systems Inc.
Grimes, IA
Class II Ongoing
Z-0171-2026 Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PAC…
Initiated 2025-09-04
American Contract Systems Inc.
Grimes, IA
Class II Ongoing
Z-2627-2025 Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2633-2025 Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2624-2025 Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2634-2025 Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2625-2025 Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0002-2026 Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0010-2026 Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, …
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0009-2026 Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, …
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0013-2026 Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, …
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0004-2026 Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2635-2025 Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0001-2026 Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2623-2025 Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0007-2026 Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0014-2026 Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2628-2025 Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842,…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0006-2026 Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0012-2026 Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, …
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2631-2025 Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0015-2026 Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0011-2026 Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, …
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0008-2026 Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2629-2025 Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0005-2026 Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1…
Initiated 2025-09-03
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-0378-2026 Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Initiated 2025-09-03
Fresenius Kabi USA, LLC
North Andover, MA
Class II Ongoing
Z-0034-2026 Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 71…
Initiated 2025-09-02
LeMaitre Vascular, Inc.
North Brunswick, NJ
Class II Ongoing
Z-0540-2026 Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is …
Initiated 2025-09-02
Berkeley Advanced Biomaterials, LLC
Berkeley, CA
Class II Ongoing
Z-0190-2026 CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0024-2026 NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-E…
Initiated 2025-08-29
Northeast Scientific Inc.
Waterbury, CT
Class II Ongoing
Z-0021-2026 NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-…
Initiated 2025-08-29
Northeast Scientific Inc.
Waterbury, CT
Class II Ongoing
Z-0194-2026 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0195-2026 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0025-2026 NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-E…
Initiated 2025-08-29
Northeast Scientific Inc.
Waterbury, CT
Class II Ongoing
Z-0016-2026 Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Initiated 2025-08-29
Getinge Disinfection Ab
Vaxjo, N/A
Class II Ongoing
Z-0198-2026 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable …
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0193-2026 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0202-2026 CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0204-2026 CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0038-2026 ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultra…
Initiated 2025-08-29
ImaCor Inc.
Jericho, NY
Class II Ongoing
Z-0018-2026 NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-…
Initiated 2025-08-29
Northeast Scientific Inc.
Waterbury, CT
Class II Ongoing
Z-0203-2026 CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micro…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0189-2026 CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extensio…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0197-2026 CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0200-2026 CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer…
Initiated 2025-08-29
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0019-2026 NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Tur…
Initiated 2025-08-29
Northeast Scientific Inc.
Waterbury, CT
Class II Ongoing
Z-0023-2026 NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-E…
Initiated 2025-08-29
Northeast Scientific Inc.
Waterbury, CT
Class II Ongoing
Z-0022-2026 NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed…
Initiated 2025-08-29
Northeast Scientific Inc.
Waterbury, CT
Class II Ongoing
Z-2606-2025 MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Si…
Initiated 2025-08-22
CooperVision, Inc.
West Henrietta, NY
Class II Ongoing
Z-0231-2026 MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu…
Initiated 2025-08-22
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-2608-2025 Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content,…
Initiated 2025-08-22
CooperVision, Inc.
West Henrietta, NY
Class II Ongoing
Z-2585-2025 i-STAT EG6+ cartridge. List Number: 03P77-25.
Initiated 2025-08-21
Abbott Point Of Care Inc.
Princeton, NJ
Class II Ongoing
Z-2576-2025 Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Initiated 2025-08-21
Folsom Metal Products, Inc.
Pelham, AL
Class II Ongoing
Z-2578-2025 Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Initiated 2025-08-21
Folsom Metal Products, Inc.
Pelham, AL
Class II Ongoing
Z-2582-2025 i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Initiated 2025-08-21
Abbott Point Of Care Inc.
Princeton, NJ
Class II Ongoing
Z-2581-2025 Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Initiated 2025-08-21
Folsom Metal Products, Inc.
Pelham, AL
Class II Ongoing
Z-2583-2025 i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Initiated 2025-08-21
Abbott Point Of Care Inc.
Princeton, NJ
Class II Ongoing
Z-2577-2025 Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Initiated 2025-08-21
Folsom Metal Products, Inc.
Pelham, AL
Class II Ongoing
Z-0411-2026 MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Initiated 2025-08-20
MicroSurgical Technology Inc
Redmond, WA
Class II Ongoing
Z-2550-2025 ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-0…
Initiated 2025-08-18
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0039-2026 CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Initiated 2025-08-18
CORNEAT VISION, LTD. Class II Ongoing
Z-2551-2025 Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Initiated 2025-08-18
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0040-2026 EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, S…
Initiated 2025-08-18
CORNEAT VISION, LTD. Class II Ongoing
Z-2586-2025 Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Initiated 2025-08-15
Maquet Cardiovascular, LLC
Wayne, NJ
Class II Ongoing
Z-2562-2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG…
Initiated 2025-08-15
Exactech, Inc.
Gainesville, FL
Class II Ongoing
Z-2587-2025 Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Initiated 2025-08-15
Maquet Cardiovascular, LLC
Wayne, NJ
Class II Ongoing
Z-2622-2025 BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00…
Initiated 2025-08-15
Mindray DS USA, Inc. dba Mindray North America
Mahwah, NJ
Class II Ongoing
Z-1276-2022 Clean Catch Urine Kit NS 178489, AHMU58A
Initiated 2022-05-02
American Contract Systems, Inc.
Kansas City, MO
Class I Ongoing
Z-1277-2022 Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Initiated 2022-05-02
American Contract Systems, Inc.
Kansas City, MO
Class I Ongoing
Z-2574-2025 UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Initiated 2025-08-13
Beckman Coulter Inc.
Brea, CA
Class II Ongoing
Z-0030-2026 Change Healthcare Radiology Solutions software version 14.2.2
Initiated 2025-08-13
CHANGE HEALTHCARE CANADA COMPANY
Richmond, N/A
Class II Ongoing
Z-2598-2025 Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Initiated 2025-08-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1809-2026 iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Initiated 2025-08-13
Beta Bionics, Inc.
Irvine, CA
Class II Ongoing
Z-2601-2025 Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Initiated 2025-08-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-2597-2025 Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Onco…
Initiated 2025-08-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-2603-2025 Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Initiated 2025-08-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-2572-2025 UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Initiated 2025-08-13
Beckman Coulter Inc.
Brea, CA
Class II Ongoing
Z-2604-2025 Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Initiated 2025-08-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-2596-2025 Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Sl…
Initiated 2025-08-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-2595-2025 Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT …
Initiated 2025-08-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-2573-2025 UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Initiated 2025-08-13
Beckman Coulter Inc.
Brea, CA
Class II Ongoing
Z-2575-2025 UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Initiated 2025-08-13
Beckman Coulter Inc.
Brea, CA
Class II Ongoing
Z-2529-2025 Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Initiated 2025-08-12
Siemens Medical Solutions USA, Inc
Malvern, PA
Class II Ongoing
Z-2563-2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461…
Initiated 2025-08-11
Agilent Technologies Denmark ApS
Glostrup, N/A
Class II Ongoing
Z-2565-2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461…
Initiated 2025-08-11
Agilent Technologies Denmark ApS
Glostrup, N/A
Class II Ongoing
Z-2564-2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461…
Initiated 2025-08-11
Agilent Technologies Denmark ApS
Glostrup, N/A
Class II Ongoing
Z-2518-2025 Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The M…
Initiated 2025-08-11
Merge Healthcare, Inc.
Hartland, WI
Class II Ongoing
Z-2594-2025 Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 …
Initiated 2025-08-08
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-2492-2025 RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStatio…
Initiated 2025-08-08
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-2488-2025 RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8…
Initiated 2025-08-08
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-2543-2025 IntelliSpace Cardiovascular, Software 8.0.0.4.
Initiated 2025-08-08
Philips Medical Systems Nederland B.V.
Eindhoven, N/A
Class II Ongoing
Z-2672-2025 Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Initiated 2025-08-08
Schiller, Ag
Baar, N/A
Class II Ongoing
Z-2491-2025 RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStatio…
Initiated 2025-08-08
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-2489-2025 RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation …
Initiated 2025-08-08
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-2494-2025 RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2.…
Initiated 2025-08-08
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-2490-2025 RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStatio…
Initiated 2025-08-08
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-2493-2025 RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStati…
Initiated 2025-08-08
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-2636-2025 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel H…
Initiated 2025-08-06
Maquet Cardiovascular, LLC
Wayne, NJ
Class II Ongoing
Z-2554-2025 Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Initiated 2025-08-06
SEASPINE ORTHOPEDICS CORPORATION
Carlsbad, CA
Class II Ongoing
Z-2505-2025 Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Pa…
Initiated 2025-08-05
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-0305-2026 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod…
Initiated 2025-08-05
Alcon Research LLC
Fort Worth, TX
Class II Ongoing
Z-0232-2026 t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, a…
Initiated 2025-08-05
Tandem Diabetes Care, Inc.
San Diego, CA
Class II Ongoing
Z-2570-2025 Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)008…
Initiated 2025-08-05
Philips Medical Systems (Cleveland) Inc
Gainesville, FL
Class II Ongoing
Z-2512-2025 Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infu…
Initiated 2025-08-05
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-0307-2026 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod…
Initiated 2025-08-05
Alcon Research LLC
Fort Worth, TX
Class II Ongoing
Z-2508-2025 Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P…
Initiated 2025-08-05
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-0306-2026 Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod…
Initiated 2025-08-05
Alcon Research LLC
Fort Worth, TX
Class II Ongoing
Z-2530-2025 Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Initiated 2025-08-04
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-2502-2025 Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresp…
Initiated 2025-08-01
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2519-2025 Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper …
Initiated 2025-07-31
Lumicell, Inc.
Newton, MA
Class II Ongoing
Z-2337-2025 Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Initiated 2025-07-30
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-0017-2026 IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIK…
Initiated 2025-07-30
S.I.N. Implant System Ltda
Sao Paulo, N/A
Class II Ongoing
Z-2560-2025 VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a …
Initiated 2025-07-29
Ortho-Clinical Diagnostics, Inc.
Rochester, NY
Class II Ongoing
Z-2615-2025 Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 …
Initiated 2025-07-28
ORTOMA AB
Goteborg, N/A
Class II Ongoing
Z-2338-2025 Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SE…
Initiated 2025-07-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-2639-2025 ZAP-X Radiosurgery System, Model: 300150
Initiated 2025-07-25
Zap Surgical Systems
San Carlos, CA
Class II Ongoing
Z-2553-2025 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /…
Initiated 2025-07-25
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-2419-2025 Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product De…
Initiated 2025-07-24
THOR Photomedicine Ltd Class II Ongoing
Z-2422-2025 Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Descript…
Initiated 2025-07-24
Dentsply IH, Inc.
Waltham, MA
Class II Ongoing
Z-2421-2025 Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Vers…
Initiated 2025-07-24
Dentsply IH, Inc.
Waltham, MA
Class II Ongoing
Z-2417-2025 Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: Th…
Initiated 2025-07-24
THOR Photomedicine Ltd Class II Ongoing
Z-2418-2025 Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product De…
Initiated 2025-07-24
THOR Photomedicine Ltd Class II Ongoing
Z-2416-2025 Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The N…
Initiated 2025-07-24
THOR Photomedicine Ltd Class II Ongoing
Z-1045-2022 Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Initiated 2022-04-09
Woodside Acquisitions Inc.
tyrone, PA
Class I Ongoing
Z-2292-2025 Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive d…
Initiated 2025-07-22
Trinity Biotech USA
Jamestown, NY
Class II Ongoing
Z-2499-2025 LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK C…
Initiated 2025-07-22
Physio-Control, Inc.
Redmond, WA
Class II Ongoing
Z-1044-2022 Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Initiated 2022-04-09
Woodside Acquisitions Inc.
tyrone, PA
Class I Ongoing
Z-2497-2025 LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-0000…
Initiated 2025-07-22
Physio-Control, Inc.
Redmond, WA
Class II Ongoing
Z-2486-2025 RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 …
Initiated 2025-07-22
Reflexion Medical, Inc.
Hayward, CA
Class II Ongoing
Z-2498-2025 LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000…
Initiated 2025-07-22
Physio-Control, Inc.
Redmond, WA
Class II Ongoing
Z-2474-2025 STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, S…
Initiated 2025-07-21
Diagnostica Stago, Inc.
Parsippany, NJ
Class II Ongoing
Z-2473-2025 STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop a…
Initiated 2025-07-21
Diagnostica Stago, Inc.
Parsippany, NJ
Class II Ongoing
Z-2475-2025 STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, …
Initiated 2025-07-21
Diagnostica Stago, Inc.
Parsippany, NJ
Class II Ongoing
Z-2476-2025 STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers o…
Initiated 2025-07-21
Diagnostica Stago, Inc.
Parsippany, NJ
Class II Ongoing
Z-2547-2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 8…
Initiated 2025-07-18
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-2549-2025 Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version…
Initiated 2025-07-18
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-2546-2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Pr…
Initiated 2025-07-18
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-2548-2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 …
Initiated 2025-07-18
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-2589-2025 SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Initiated 2025-07-17
C.R. Bard Inc
Covington, GA
Class II Ongoing
Z-2590-2025 SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Initiated 2025-07-17
C.R. Bard Inc
Covington, GA
Class II Ongoing
Z-2552-2025 Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 0…
Initiated 2025-07-17
Quest International, Inc.
Doral, FL
Class II Ongoing
Z-2620-2025 Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Initiated 2025-07-15
Stryker Communications
Flower Mound, TX
Class II Ongoing
Z-2288-2025 Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Initiated 2025-07-15
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-2420-2025 Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F…
Initiated 2025-07-14
MAQUET GMBH Class II Ongoing
Z-2223-2025 Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Initiated 2025-07-11
Remel, Inc
Lenexa, KS
Class II Ongoing
Z-2226-2025 Blood/MacConkey Biplate 100/PK, Product Number R02049
Initiated 2025-07-11
Remel, Inc
Lenexa, KS
Class II Ongoing
Z-2224-2025 Strep Selective II Agar, Product Number R01859
Initiated 2025-07-11
Remel, Inc
Lenexa, KS
Class II Ongoing
Z-2609-2025 FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test in…
Initiated 2025-07-10
Biofire Defense
Salt Lake City, UT
Class II Ongoing
Z-2285-2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 34…
Initiated 2025-07-09
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-2286-2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 34…
Initiated 2025-07-09
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-2452-2025 The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utili…
Initiated 2025-07-08
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-2340-2025 Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimu…
Initiated 2025-07-08
Boston Scientific Neuromodulation Corporation
Valencia, CA
Class II Ongoing
Z-2558-2025 Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Initiated 2025-07-08
Boston Scientific Neuromodulation Corporation
Valencia, CA
Class II Ongoing
Z-2237-2025 BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Initiated 2025-07-08
Becton, Dickinson and Company, BD Bio Sciences
Milpitas, CA
Class II Ongoing
Z-2238-2025 BD Trucount Controls, 30 Test - REF: 340335
Initiated 2025-07-08
Becton, Dickinson and Company, BD Bio Sciences
Milpitas, CA
Class II Ongoing
Z-2272-2025 epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Initiated 2025-07-07
Siemens Healthcare Diagnostics Inc
Norwood, MA
Class II Ongoing
Z-2442-2025 Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head …
Initiated 2025-07-03
Orascoptic Surgical Acuity
Orange, CA
Class II Ongoing
Z-2445-2025 Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
Initiated 2025-07-03
Orascoptic Surgical Acuity
Orange, CA
Class II Ongoing
Z-2444-2025 Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
Initiated 2025-07-03
Orascoptic Surgical Acuity
Orange, CA
Class II Ongoing
Z-2342-2025 GE HealthCare OEC 9900 Elite C-arm Systems.
Initiated 2025-07-02
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-2341-2025 GE HealthCare OEC 9800.
Initiated 2025-07-02
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-2287-2025 Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Initiated 2025-07-02
Spark Biomedical Inc
Richmond, TX
Class II Ongoing
Z-2637-2025 JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Mod…
Initiated 2025-07-01
North American Rescue LLC.
Greer, SC
Class II Ongoing
Z-2282-2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray D…
Initiated 2025-07-01
Carefree Surgical Specialties
Nampa, ID
Class II Ongoing
Z-2284-2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-…
Initiated 2025-07-01
Carefree Surgical Specialties
Nampa, ID
Class II Ongoing
Z-2283-2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray D…
Initiated 2025-07-01
Carefree Surgical Specialties
Nampa, ID
Class II Ongoing
Z-2281-2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectab…
Initiated 2025-07-01
Carefree Surgical Specialties
Nampa, ID
Class II Ongoing
Z-2280-2025 Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S …
Initiated 2025-06-30
SPINEART SA
Plan-Les-Ouates, N/A
Class II Ongoing
Z-2211-2025 Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2215-2025 SmartPath to dStream for 3.0T Model Number (REF): 782145;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2205-2025 Ingenia 1.5T S Model Number (REF): 781347;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2206-2025 Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2213-2025 MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2208-2025 Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2200-2025 Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2218-2025 Upgrade to MR 7700 Model Number (REF): 782130;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2112-2025 Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
Initiated 2025-06-30
Beyond Laser Systems, LLC
Austin, TX
Class II Ongoing
Z-2207-2025 Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2279-2025 Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S …
Initiated 2025-06-30
SPINEART SA
Plan-Les-Ouates, N/A
Class II Ongoing
Z-2210-2025 Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2111-2025 Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
Initiated 2025-06-30
Beyond Laser Systems, LLC
Austin, TX
Class II Ongoing
Z-2201-2025 Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2217-2025 SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2189-2025 Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper…
Initiated 2025-06-30
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-2174-2025 HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibr…
Initiated 2025-06-30
HeartSine Technologies Ltd Class II Ongoing
Z-2203-2025 Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
Initiated 2025-06-30
Philips North America
Cambridge, MA
Class II Ongoing
Z-2194-2025 LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Initiated 2025-06-27
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-2331-2025 Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; …
Initiated 2025-06-27
Spiggle & Theis Mt Gmbh
Dieburg, N/A
Class II Ongoing
Z-2230-2025 RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Initiated 2025-06-26
Siemens Healthcare Diagnostics Inc
Norwood, MA
Class II Ongoing
Z-2267-2025 DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Initiated 2025-06-25
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-2271-2025 DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Initiated 2025-06-25
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-2268-2025 DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Initiated 2025-06-25
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-2278-2025 FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Initiated 2025-06-25
Boston Scientific Corporation
Saint Paul, MN
Class II Ongoing
Z-2270-2025 DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Initiated 2025-06-25
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-2235-2025 LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-…
Initiated 2025-06-24
Fresenius Kabi USA, LLC
North Andover, MA
Class II Ongoing
Z-2555-2025 PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Initiated 2025-06-24
Orthofix U.S. LLC
Lewisville, TX
Class II Ongoing
Z-2232-2025 LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Initiated 2025-06-24
Fresenius Kabi USA, LLC
North Andover, MA
Class II Ongoing
Z-2178-2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Initiated 2025-06-23
Steris Corporation
Mentor, OH
Class II Ongoing
Z-2177-2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Initiated 2025-06-23
Steris Corporation
Mentor, OH
Class II Ongoing
Z-2168-2025 Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt …
Initiated 2025-06-18
Medtronic, Inc.
Mounds View, MN
Class II Ongoing
Z-2171-2025 Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Initiated 2025-06-18
Stryker Corporation
San Jose, CA
Class II Ongoing
Z-2169-2025 Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr…
Initiated 2025-06-18
Medtronic, Inc.
Mounds View, MN
Class II Ongoing
Z-2222-2025 Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. …
Initiated 2025-06-18
Osteotec Limited Class II Ongoing
Z-2545-2025 QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Initiated 2025-06-17
Quidel Corporation
San Diego, CA
Class II Ongoing
Z-2521-2025 MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended t…
Initiated 2025-06-17
CARIS LIFE SCIENCES
Tempe, AZ
Class II Ongoing
Z-2165-2025 Biofinity XR Toric Contact Lens
Initiated 2025-06-16
CooperVision, Inc.
Scottsville, NY
Class II Ongoing
Z-2453-2025 BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer…
Initiated 2025-06-16
BD SWITZERLAND SARL Class II Ongoing
Z-1076-2022 Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85…
Initiated 2022-03-03
Atrium Medical Corporation
Merrimack, NH
Class I Ongoing
Z-1077-2022 iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 …
Initiated 2022-03-03
Atrium Medical Corporation
Merrimack, NH
Class I Ongoing
Z-2221-2025 Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8…
Initiated 2025-06-13
Volcano Corp
San Diego, CA
Class II Ongoing
Z-2073-2025 VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c…
Initiated 2025-06-12
Ortho-Clinical Diagnostics, Inc.
Rochester, NY
Class II Ongoing
Z-2012-2025 Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,…
Initiated 2025-06-11
RECORDATI RARE DISEASES INC.
Bridgewater, NJ
Class II Ongoing
Z-2137-2025 Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Initiated 2025-06-11
CooperSurgical, Inc.
Trumbull, CT
Class II Ongoing
Z-2219-2025 ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt…
Initiated 2025-06-11
FUJIFILM Healthcare Americas Corporation
Lexington, MA
Class II Ongoing
Z-2190-2025 BostonSight SCLERAL Lens
Initiated 2025-06-10
Boston Foundation For Sight
Needham, MA
Class II Ongoing
Z-2191-2025 BostonSight PROSE Lens.
Initiated 2025-06-10
Boston Foundation For Sight
Needham, MA
Class II Ongoing
Z-2106-2025 Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F …
Initiated 2025-06-10
Boston Scientific Corporation
Saint Paul, MN
Class II Ongoing
Z-2103-2025 VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (18…
Initiated 2025-06-10
Boston Scientific Corporation
Saint Paul, MN
Class II Ongoing
Z-2104-2025 VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Devic…
Initiated 2025-06-10
Boston Scientific Corporation
Saint Paul, MN
Class II Ongoing
Z-2105-2025 VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACRO…
Initiated 2025-06-10
Boston Scientific Corporation
Saint Paul, MN
Class II Ongoing
Z-2120-2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Num…
Initiated 2025-06-10
Ortho-Clinical Diagnostics, Inc.
Rochester, NY
Class II Ongoing
Z-2121-2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu…
Initiated 2025-06-10
Ortho-Clinical Diagnostics, Inc.
Rochester, NY
Class II Ongoing
Z-2485-2025 Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect …
Initiated 2025-06-06
Boston Scientific Neuromodulation Corporation
Valencia, CA
Class II Ongoing
Z-2119-2025 Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A P…
Initiated 2025-06-05
Waismed Ltd.
Herzliya, N/A
Class II Ongoing
Z-2118-2025 Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A …
Initiated 2025-06-05
Waismed Ltd.
Herzliya, N/A
Class II Ongoing
Z-2295-2025 Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-1334…
Initiated 2025-06-05
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-2294-2025 Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Initiated 2025-06-05
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-1982-2025 UROSKOP Omnia Max. Model Number: 10762473
Initiated 2025-06-04
Siemens Medical Solutions USA, Inc
Malvern, PA
Class II Ongoing
Z-2089-2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Initiated 2025-06-04
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-2088-2025 ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Initiated 2025-06-04
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-2134-2025 Azurion 7 M20. Fluoroscopic X-Ray System.
Initiated 2025-06-04
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Best, N/A
Class II Ongoing
Z-2116-2025 SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200…
Initiated 2025-06-03
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-2076-2025 REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Initiated 2025-06-03
C.R. Bard Inc
Covington, GA
Class II Ongoing
Z-2074-2025 BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr …
Initiated 2025-06-03
C.R. Bard Inc
Covington, GA
Class II Ongoing
Z-2513-2025 Medshape Universal Joints, REF: DNE-9000-UJ
Initiated 2025-06-02
Medshape, INC.
Atlanta, GA
Class II Ongoing
Z-1931-2025 Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Initiated 2025-05-29
Philips North America
Cambridge, MA
Class II Ongoing
Z-1932-2025 Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Initiated 2025-05-29
Philips North America
Cambridge, MA
Class II Ongoing
Z-1936-2025 SmartPath to dStream for 1.5T¿; Product Number: 782146;
Initiated 2025-05-29
Philips North America
Cambridge, MA
Class II Ongoing
Z-1929-2025 Intera 1.5T Achieva IT Nova Product Number: 781175
Initiated 2025-05-29
Philips North America
Cambridge, MA
Class II Ongoing
Z-2053-2025 Philips eL18-4 EMT Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2051-2025 Philips C9-5EC Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2052-2025 Philips eL18-4 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2050-2025 Philips C5-2 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2054-2025 Philips L12-3 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2065-2025 Philips X6-1 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2067-2025 Philips X8-2t Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2018-2025 CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Tri…
Initiated 2025-05-28
Terumo Cardiovascular Systems Corporation
Ann Arbor, MI
Class II Ongoing
Z-2062-2025 Philips V6-2 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2058-2025 Philips S5-1 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2059-2025 Philips S7-2 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2048-2025 Philips 3D9-3v Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2066-2025 Philips X7-2t Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2064-2025 Philips X5-1 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2061-2025 Philips S8-3t Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2068-2025 Philips XL14-3 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2049-2025 Philips C5-1 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-2055-2025 Philips L12-4 Transducer.
Initiated 2025-05-28
Philips Ultrasound, Inc
Reedsville, PA
Class II Ongoing
Z-1914-2025 Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Initiated 2025-05-28
Stryker GmbH Class II Ongoing
Z-1957-2025 KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17…
Initiated 2025-05-27
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-2069-2025 Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-5015…
Initiated 2025-05-23
CORIN MEDICAL, LTD. Class II Ongoing
Z-2130-2025 SIGNA Architect
Initiated 2025-05-23
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1927-2025 EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory int…
Initiated 2025-05-23
QUANTUM SURGICAL SAS Class II Ongoing
Z-2131-2025 SIGNA Architect AIR
Initiated 2025-05-23
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-2043-2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAW…
Initiated 2025-05-23
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-2044-2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX…
Initiated 2025-05-23
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-2072-2025 Change Healthcare Cardiology Hemodynamics Software
Initiated 2025-05-22
CHANGE HEALTHCARE CANADA COMPANY Class II Ongoing
Z-1939-2025 Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Initiated 2025-05-22
Stryker GmbH Class II Ongoing
Z-2071-2025 Change Healthcare Cardiology Hemo Software
Initiated 2025-05-22
CHANGE HEALTHCARE CANADA COMPANY Class II Ongoing
Z-2007-2025 REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Initiated 2025-05-21
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT
Class II Ongoing
Z-2006-2025 REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOn…
Initiated 2025-05-21
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT
Class II Ongoing
Z-2005-2025 REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Initiated 2025-05-21
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT
Class II Ongoing
Z-2002-2025 REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Initiated 2025-05-21
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT
Class II Ongoing
Z-1999-2025 REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Initiated 2025-05-21
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT
Class II Ongoing
Z-2003-2025 REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO,…
Initiated 2025-05-21
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT
Class II Ongoing
Z-2001-2025 REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Initiated 2025-05-21
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT
Class II Ongoing
Z-2004-2025 REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERIL…
Initiated 2025-05-21
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT
Class II Ongoing
Z-2023-2025 BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cul…
Initiated 2025-05-20
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-2042-2025 My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Sho…
Initiated 2025-05-20
Onkos Surgical, Inc.
Parsippany, NJ
Class II Ongoing
Z-2025-2025 PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Initiated 2025-05-19
Limacorporate S.p.A Class II Ongoing
Z-2330-2025 Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Descript…
Initiated 2025-05-16
Drs Vascular, Inc
San Jose, CA
Class II Ongoing
Z-1822-2026 Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software …
Initiated 2025-05-16
THERAKOS DEVELOPMENT LIMITED
Blanchardstown, N/A
Class II Ongoing
Z-1995-2025 Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Initiated 2025-05-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1956-2025 Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Initiated 2025-05-15
Contamac Solutions, Inc.
Grand Junction, CO
Class II Ongoing
Z-1794-2025 Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1800-2025 Product Name: Ingenia 3.0T CX; Model Number: 781271;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1799-2025 Product Name: Ingenia 1.5T CX; Model Number: 781262;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1805-2025 Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1803-2025 Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1797-2025 Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1796-2025 Product Name: Ingenia 1.5T S; Model Number: 781347;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1789-2025 Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1801-2025 Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1802-2025 Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1791-2025 Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1798-2025 Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Initiated 2025-05-13
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1973-2025 BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Initiated 2025-05-12
BD SWITZERLAND SARL Class II Ongoing
Z-2070-2025 The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma con…
Initiated 2025-05-12
HemoCue AB Class II Ongoing
Z-1971-2025 BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF:…
Initiated 2025-05-12
BD SWITZERLAND SARL Class II Ongoing
Z-1964-2025 Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Initiated 2025-05-12
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1974-2025 BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Initiated 2025-05-12
BD SWITZERLAND SARL Class II Ongoing
Z-1970-2025 Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y…
Initiated 2025-05-12
BD SWITZERLAND SARL Class II Ongoing
Z-1962-2025 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Initiated 2025-05-09
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-2039-2025 Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S…
Initiated 2025-05-09
Ortho-Clinical Diagnostics, Inc.
Rochester, NY
Class II Ongoing
Z-0663-2022 Philips Respironics V60 Plus Ventilator Part Number 1138747
Initiated 2022-01-24
Respironics California, LLC
Carlsbad, CA
Class I Ongoing
Z-1980-2025 GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Initiated 2025-05-08
Ohio Medical Corporation
Gurnee, IL
Class II Ongoing
Z-0662-2022 Philips Respironics V60 Ventilator Part Number 1053617
Initiated 2022-01-24
Respironics California, LLC
Carlsbad, CA
Class I Ongoing
Z-2017-2025 Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4…
Initiated 2025-05-08
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-1925-2025 Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/…
Initiated 2025-05-07
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Class II Ongoing
Z-1975-2025 Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (End…
Initiated 2025-05-07
MicroAire Surgical Instruments, LLC
Charlottesville, VA
Class II Ongoing
Z-1922-2025 Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalo…
Initiated 2025-05-06
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1812-2025 PhenoMATRIX
Initiated 2025-05-06
Copan WASP
Brescia, N/A
Class II Ongoing
Z-1816-2025 Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043…
Initiated 2025-05-06
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1911-2025 Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Initiated 2025-05-05
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1906-2025 Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syste…
Initiated 2025-05-05
Dexcom, Inc.
San Diego, CA
Class II Ongoing
Z-0372-2026 SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL…
Initiated 2025-05-05
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Austell, GA
Class II Ongoing
Z-1870-2025 Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Initiated 2025-05-02
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-1910-2025 ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Initiated 2025-05-02
Healthmark Industries Co., Inc.
Fraser, MI
Class II Ongoing
Z-1871-2025 Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Initiated 2025-05-02
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-1937-2025 BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Initiated 2025-05-02
Copan Italia Class II Ongoing
Z-1947-2025 Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; inv…
Initiated 2025-05-01
Remel, Inc
Lenexa, KS
Class II Ongoing
Z-2172-2025 The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop leng…
Initiated 2025-05-01
Implant Direct Sybron Manufacturing LLC
Westlake Village, CA
Class II Ongoing
Z-1907-2025 Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot …
Initiated 2025-04-30
Beckman Coulter Mishima K.K.
Sunto-Gun, N/A
Class II Ongoing
Z-1908-2025 Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot …
Initiated 2025-04-30
Beckman Coulter Mishima K.K.
Sunto-Gun, N/A
Class II Ongoing
Z-1749-2025 Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain …
Initiated 2025-04-28
Abbott Molecular, Inc.
Des Plaines, IL
Class II Ongoing
Z-1748-2025 Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (…
Initiated 2025-04-28
Abbott Molecular, Inc.
Des Plaines, IL
Class II Ongoing
Z-2108-2025 Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog …
Initiated 2025-04-28
Alcon Research LLC
Fort Worth, TX
Class II Ongoing
Z-1955-2025 Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No …
Initiated 2025-04-25
Tecfen Medical
Santa Barbara, CA
Class II Ongoing
Z-1954-2025 Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software …
Initiated 2025-04-25
Tecfen Medical
Santa Barbara, CA
Class II Ongoing
Z-1949-2025 Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No soft…
Initiated 2025-04-25
Tecfen Medical
Santa Barbara, CA
Class II Ongoing
Z-1952-2025 Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No …
Initiated 2025-04-25
Tecfen Medical
Santa Barbara, CA
Class II Ongoing
Z-1854-2025 SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1846-2025 ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1836-2025 ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1837-2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1965-2025 iBOT PMD with software version 01.05.24. Personal Mobility Device.
Initiated 2025-04-24
Mobius Mobility LLC
Manchester, NH
Class II Ongoing
Z-1842-2025 ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1851-2025 ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1850-2025 ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1843-2025 ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1825-2025 ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1855-2025 HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1831-2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1840-2025 ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1828-2025 BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1847-2025 ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1838-2025 HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1844-2025 ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1827-2025 HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Initiated 2025-04-24
Mckesson Medical-Surgical Inc. Corporate Office
Richmond, VA
Class II Ongoing
Z-1885-2025 Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Initiated 2025-04-23
Mozarc Medical US LLC
Mansfield, MA
Class II Ongoing
Z-1886-2025 Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Initiated 2025-04-23
Mozarc Medical US LLC
Mansfield, MA
Class II Ongoing
Z-1913-2025 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Initiated 2025-04-23
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-1887-2025 Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Initiated 2025-04-23
Mozarc Medical US LLC
Mansfield, MA
Class II Ongoing
Z-1889-2025 MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Initiated 2025-04-23
Mozarc Medical US LLC
Mansfield, MA
Class II Ongoing
Z-2231-2025 3M Ranger Irrigation Fluid Warming Set, REF 24750
Initiated 2025-04-22
3M Company
Saint Paul, MN
Class II Ongoing
Z-1858-2025 Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (…
Initiated 2025-04-22
C-RAD POSITIONING AB
Uppsala, N/A
Class II Ongoing
Z-1786-2025 Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08…
Initiated 2025-04-17
Cook Incorporated
Bloomington, IN
Class II Ongoing
Z-1787-2025 Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08…
Initiated 2025-04-17
Cook Incorporated
Bloomington, IN
Class II Ongoing
Z-1729-2025 Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Initiated 2025-04-15
Remote Diagnostic Technologies Ltd.
Farnborough, N/A
Class II Ongoing
Z-1821-2025 Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Initiated 2025-04-15
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-1822-2025 ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Initiated 2025-04-15
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-1856-2025 Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219…
Initiated 2025-04-14
Prismatik Dentalcraft, Inc.
Irvine, CA
Class II Ongoing
Z-1876-2025 VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9…
Initiated 2025-04-14
Ortho-Clinical Diagnostics, Inc.
Rochester, NY
Class II Ongoing
Z-1738-2025 Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Initiated 2025-04-10
Tornier S.A.S.
Montbonnot-Saint-Martin, N/A
Class II Ongoing
Z-1766-2025 Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Initiated 2025-04-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1747-2025 FoundationOne Companion Diagnostic (F1CDx)
Initiated 2025-04-09
Foundation Medicine, Inc.
Cambridge, MA
Class II Ongoing
Z-1728-2025 Artix MT Thrombectomy Device, REF: 32-102
Initiated 2025-04-08
Inari Medical - Oak Canyon
Irvine, CA
Class II Ongoing
Z-2028-2025 REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4…
Initiated 2025-04-08
Beckman Coulter Inc.
Brea, CA
Class II Ongoing
Z-1722-2025 Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub…
Initiated 2025-04-07
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1740-2025 IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Initiated 2025-04-07
Philips Medical Systems Nederland B.V.
Eindhoven, N/A
Class II Ongoing
Z-1718-2025 Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Initiated 2025-04-07
SCIENCE & BIO MATERIALS
Lourdes, N/A
Class II Ongoing
Z-0493-2022 Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous …
Initiated 2021-12-22
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-0494-2022 Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides …
Initiated 2021-12-22
Philips Respironics, Inc.
Murrysville, PA
Class I Ongoing
Z-1724-2025 INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Initiated 2025-04-04
Integra LifeSciences Corp. (NeuroSciences)
Princeton, NJ
Class II Ongoing
Z-1715-2025 Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers…
Initiated 2025-04-04
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1769-2025 KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F …
Initiated 2025-04-04
Klinika Mdical Gmb Class II Ongoing
Z-1700-2025 Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3)…
Initiated 2025-04-03
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-1702-2025 Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-…
Initiated 2025-04-03
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-1704-2025 Enhanced Verify Evaluation Handset (CFN HH90130FA)
Initiated 2025-04-03
Medtronic Neuromodulation
Minneapolis, MN
Class II Ongoing
Z-1699-2025 Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 88…
Initiated 2025-04-03
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-1721-2025 Washer Disinfector Aquadis 56; Model Number: 56M
Initiated 2025-04-02
Getinge Disinfection Ab
Vaxjo, N/A
Class II Ongoing
Z-1720-2025 Washer Disinfector Aquadis 56; Model Number: 56A
Initiated 2025-04-02
Getinge Disinfection Ab
Vaxjo, N/A
Class II Ongoing
Z-1703-2025 myQA iON; Article Number: MQ10-000;
Initiated 2025-04-01
IBA Dosimetry GmbH
Schwarzenbruck, N/A
Class II Ongoing
Z-1660-2025 Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Initiated 2025-04-01
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1678-2025 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Rese…
Initiated 2025-03-31
Belmont Instrument LLC
Billerica, MA
Class II Ongoing
Z-1741-2025 Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
Initiated 2025-03-31
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-1859-2025 Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning…
Initiated 2025-03-31
Ultra Clean Systems, Inc.
Oldsmar, FL
Class II Ongoing
Z-1743-2025 Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Initiated 2025-03-31
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-1674-2025 Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperth…
Initiated 2025-03-31
Belmont Instrument LLC
Billerica, MA
Class II Ongoing
Z-1734-2025 GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position …
Initiated 2025-03-27
Galt Medical Corporation
Garland, TX
Class II Ongoing
Z-1663-2025 Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Initiated 2025-03-27
IHB OPERATIONS B.V.
Zwolle, N/A
Class II Ongoing
Z-1732-2025 B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introduce…
Initiated 2025-03-27
Galt Medical Corporation
Garland, TX
Class II Ongoing
Z-1733-2025 B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV…
Initiated 2025-03-27
Galt Medical Corporation
Garland, TX
Class II Ongoing
Z-1569-2025 restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for …
Initiated 2025-03-25
Conformis Inc.
Wilmington, MA
Class II Ongoing
Z-1776-2025 Intera 1.5T Master/Nova, Model Number: 781106;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1558-2025 Welch Allyn Connex Vital Signs Monitor (CVSM):
Initiated 2025-03-24
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1783-2025 SmartPath to dStream for 3.0T, Model Number: 782145;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1775-2025 Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1687-2025 IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure…
Initiated 2025-03-24
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-1559-2025 Welch Allyn CONNEX Accessory Power Management Stand:
Initiated 2025-03-24
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1648-2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained…
Initiated 2025-03-24
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-1782-2025 SmartPath to dStream for 1.5T, Model Number: 782146;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1689-2025 IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure g…
Initiated 2025-03-24
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-1772-2025 Intera 1.0T Omni/Stellar, Model Number: 781102;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1719-2025 Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Initiated 2025-03-24
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1770-2025 Enterprise 1.5T, Model Number: 781145;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1686-2025 IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure …
Initiated 2025-03-24
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-1646-2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constr…
Initiated 2025-03-24
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-1777-2025 Intera 1.5T Omni/Stellar, Model Number: 781104;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1771-2025 Intera 0.5T Standard, Model Number: 781101;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1780-2025 Intera 3.0T Quasar Dual, Model Number: 781150;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1778-2025 Intera 1.5T Power/Pulsar, Model Number: 781105;
Initiated 2025-03-24
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1665-2025 The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a…
Initiated 2025-03-20
Abbott Molecular, Inc.
Des Plaines, IL
Class II Ongoing
Z-1622-2025 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len…
Initiated 2025-03-20
Maquet Cardiovascular, LLC
Wayne, NJ
Class II Ongoing
Z-1707-2025 Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Initiated 2025-03-19
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1709-2025 Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; …
Initiated 2025-03-19
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1706-2025 Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Initiated 2025-03-19
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1705-2025 Medline Sterile Water, USP, 100mL, REF RDI30295
Initiated 2025-03-19
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1712-2025 Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Initiated 2025-03-19
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1684-2025 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Softwa…
Initiated 2025-03-19
Siemens Healthcare Diagnostics Inc
Norwood, MA
Class II Ongoing
Z-1652-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software v…
Initiated 2025-03-18
Abbott Laboratories
Abbott Park, IL
Class II Ongoing
Z-1806-2025 META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Initiated 2025-03-18
Smith & Nephew, Inc.
Memphis, TN
Class II Ongoing
Z-1654-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v…
Initiated 2025-03-18
Abbott Laboratories
Abbott Park, IL
Class II Ongoing
Z-1655-2025 Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software v…
Initiated 2025-03-18
Abbott Laboratories
Abbott Park, IL
Class II Ongoing
Z-1643-2025 Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Initiated 2025-03-17
Abbott
Plymouth, MN
Class II Ongoing
Z-1672-2025 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 …
Initiated 2025-03-17
Beckman Coulter Inc.
Brea, CA
Class II Ongoing
Z-1644-2025 Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Initiated 2025-03-17
Abbott
Plymouth, MN
Class II Ongoing
Z-1860-2025 DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Initiated 2025-03-14
Pro-Med Instruments Gmbh
Freiburg Im Breisgau, N/A
Class II Ongoing
Z-1640-2025 Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Initiated 2025-03-14
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-1641-2025 Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca…
Initiated 2025-03-14
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-1545-2025 BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen…
Initiated 2025-03-11
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-1551-2025 Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Initiated 2025-03-11
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-1554-2025 Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Initiated 2025-03-10
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-1513-2025 PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Initiated 2025-03-07
Ethicon Endo Surgery, LLC
Guaynabo, PR
Class II Ongoing
Z-1515-2025 PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Initiated 2025-03-07
Ethicon Endo Surgery, LLC
Guaynabo, PR
Class II Ongoing
Z-1555-2025 Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H…
Initiated 2025-03-06
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1548-2025 MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
Initiated 2025-03-05
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1547-2025 MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Initiated 2025-03-05
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1546-2025 MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA5…
Initiated 2025-03-05
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1575-2025 Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V…
Initiated 2025-03-04
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME
Class II Ongoing
Z-1576-2025 Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc…
Initiated 2025-03-04
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME
Class II Ongoing
Z-1572-2025 Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V…
Initiated 2025-03-04
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME
Class II Ongoing
Z-1574-2025 Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version…
Initiated 2025-03-04
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME
Class II Ongoing
Z-1543-2025 Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P…
Initiated 2025-03-04
Medtronic Neuromodulation
Minneapolis, MN
Class II Ongoing
Z-1605-2025 Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1614-2025 Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTI…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1618-2025 Refer to RES
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1612-2025 Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1599-2025 Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH …
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1587-2025 Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1611-2025 Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAG…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1595-2025 Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Mod…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1601-2025 Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1613-2025 Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GN…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1610-2025 Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1606-2025 Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1403-2025 Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No…
Initiated 2025-03-03
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Oranmore, N/A
Class II Ongoing
Z-1589-2025 Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1619-2025 Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHR…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1590-2025 Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOG…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1593-2025 Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE …
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1600-2025 Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1597-2025 Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model N…
Initiated 2025-03-03
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1500-2025 Phoroptor VRx Digital Refraction System Model Numbers: 16241
Initiated 2025-02-28
Reichert, Inc.
Depew, NY
Class II Ongoing
Z-1501-2025 Phoroptor VRx Digital Refraction System Model Numbers: 16242
Initiated 2025-02-28
Reichert, Inc.
Depew, NY
Class II Ongoing
Z-1408-2025 Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Initiated 2025-02-27
Premier Dental Products Co
Plymouth Meeting, PA
Class II Ongoing
Z-1325-2025 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software V…
Initiated 2025-02-26
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-1472-2025 Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1476-2025 Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1475-2025 Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1477-2025 Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1419-2025 Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Initiated 2025-02-25
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1482-2025 Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1413-2025 Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Initiated 2025-02-25
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1471-2025 Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1422-2025 Baxter TruSystem 7500, Product Code 4091000
Initiated 2025-02-25
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1410-2025 Baxter Stationary column TruSystem 7500, Product Code 1717020
Initiated 2025-02-25
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1416-2025 Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Initiated 2025-02-25
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1418-2025 Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Initiated 2025-02-25
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1481-2025 Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Nu…
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1473-2025 Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1470-2025 Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1478-2025 Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number…
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1479-2025 Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number…
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1474-2025 Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Initiated 2025-02-25
Stryker Corporation
Portage, MI
Class II Ongoing
Z-1466-2025 Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model…
Initiated 2025-02-24
Checkpoint Surgical Inc
Cleveland, OH
Class II Ongoing
Z-0383-2022 Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Crania…
Initiated 2021-11-11
Medtronic Navigation, Inc.
Louisville, CO
Class I Ongoing
Z-1432-2025 Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: …
Initiated 2025-02-20
Orthofix U.S. LLC
Lewisville, TX
Class II Ongoing
Z-1371-2025 Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control…
Initiated 2025-02-20
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-1454-2025 Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed qu…
Initiated 2025-02-20
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-1267-2025 MIM software; System, Image Processing, Radiological
Initiated 2025-02-19
MIM Software Inc
Cleveland, OH
Class II Ongoing
Z-1531-2025 Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOL…
Initiated 2025-02-19
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1378-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediat…
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-1385-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated…
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-0396-2026 Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-1377-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Se…
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-1379-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampli…
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-0393-2026 Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0379-2026 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0397-2026 Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0381-2026 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-1384-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated…
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-0399-2026 Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0385-2026 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0404-2026 Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-1380-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - …
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-1383-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad…
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-0405-2026 Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0400-2026 Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0386-2026 Trial Tampon Box; Model Number: FG-TMP-REF04050504;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0406-2026 Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0389-2026 Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-1382-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intub…
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-0394-2026 Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0398-2026 Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-1381-2025 Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediat…
Initiated 2025-02-17
Oridion Medical 1987 Ltd.
Jerusalem, N/A
Class II Ongoing
Z-0391-2026 Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-0407-2026 Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Initiated 2025-02-17
DAYE (ANNE'S DAY LTD)
London, N/A
Class II Ongoing
Z-1372-2025 Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Initiated 2025-02-14
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-1404-2025 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Initiated 2025-02-14
Smiths Medical ASD, Inc.
Minneapolis, MN
Class II Ongoing
Z-1374-2025 Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Initiated 2025-02-14
Waldemar Link GmbH & Co. KG (Mfg Site)
Norderstedt, N/A
Class II Ongoing
Z-1405-2025 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Initiated 2025-02-14
Smiths Medical ASD, Inc.
Minneapolis, MN
Class II Ongoing
Z-1201-2025 remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Initiated 2025-02-13
Remel, Inc
Lenexa, KS
Class II Ongoing
Z-1321-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Descrip…
Initiated 2025-02-13
ZOLL Medical Corporation
Chelmsford, MA
Class II Ongoing
Z-1364-2025 Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO D…
Initiated 2025-02-13
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1319-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-…
Initiated 2025-02-13
ZOLL Medical Corporation
Chelmsford, MA
Class II Ongoing
Z-1370-2025 Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile su…
Initiated 2025-02-13
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1320-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-…
Initiated 2025-02-13
ZOLL Medical Corporation
Chelmsford, MA
Class II Ongoing
Z-1322-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) …
Initiated 2025-02-13
ZOLL Medical Corporation
Chelmsford, MA
Class II Ongoing
Z-1316-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-…
Initiated 2025-02-13
ZOLL Medical Corporation
Chelmsford, MA
Class II Ongoing
Z-1317-2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version…
Initiated 2025-02-13
ZOLL Medical Corporation
Chelmsford, MA
Class II Ongoing
Z-1369-2025 Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Initiated 2025-02-13
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1368-2025 Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUC…
Initiated 2025-02-13
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1366-2025 Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Initiated 2025-02-13
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1431-2025 namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRA…
Initiated 2025-02-12
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1428-2025 namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Initiated 2025-02-12
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1430-2025 namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
Initiated 2025-02-12
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1329-2025 Z1 Femoral Hip System, Product Number 611777612
Initiated 2025-02-12
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-1453-2025 Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pac…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1439-2025 Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNE…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1463-2025 Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1445-2025 Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1464-2025 Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack N…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1441-2025 Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Numb…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1461-2025 Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, P…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1443-2025 Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1435-2025 Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1438-2025 Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DY…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1447-2025 Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, …
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1446-2025 Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1452-2025 Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Numbe…
Initiated 2025-02-11
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1389-2025 Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffu…
Initiated 2025-02-10
Immuno-Mycologics, Inc
Norman, OK
Class II Ongoing
Z-1392-2025 Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Initiated 2025-02-10
Brainlab AG
Munich, N/A
Class II Ongoing
Z-1307-2025 CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in…
Initiated 2025-02-07
CardioFocus, Inc.
Marlborough, MA
Class II Ongoing
Z-1358-2025 MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1338-2025 LABOR & DELIVERY PACK, Model Nos LLLD19H
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1343-2025 CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1295-2025 AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ…
Initiated 2025-02-06
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-1357-2025 GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1336-2025 C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1354-2025 DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1348-2025 DELIVERY PACK , Model No SGDV22D-01 SGDV22E
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1339-2025 OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1333-2025 HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1350-2025 LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1352-2025 LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1346-2025 CYSTO , Model No SACY80R
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1332-2025 DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1344-2025 LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1362-2025 VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1335-2025 CYSTO PACK , Model N. HKCY31A
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1341-2025 BORN ON ARRIVAL KIT , Model No LLBN11B
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1345-2025 URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1340-2025 GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1342-2025 C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1356-2025 AV FISTULA , Model No UTAV77T
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-1361-2025 THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Initiated 2025-02-06
American Contract Systems Inc
Tiffin, OH
Class II Ongoing
Z-2569-2025 MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data proce…
Initiated 2025-02-05
Medical Information Technology, Inc.
Canton, MA
Class II Ongoing
Z-1427-2025 CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web…
Initiated 2025-02-03
St. Jude Medical
Atlanta, GA
Class II Ongoing
Z-2323-2025 HemosIL LMW Heparin Controls; Part Number: 0020300200;
Initiated 2025-02-03
Instrumentation Laboratory
Bedford, MA
Class II Ongoing
Z-1240-2025 Brivo MR355, NMRI system
Initiated 2025-01-31
GE Healthcare (China) Co., Ltd.
Beijing, N/A
Class II Ongoing
Z-1265-2025 MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Initiated 2025-01-31
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1312-2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R…
Initiated 2025-01-31
Aesculap Inc
Center Valley, PA
Class II Ongoing
Z-1239-2025 SIGNA Creator, SIGNA Explorer, NMRI systems
Initiated 2025-01-31
GE Healthcare (China) Co., Ltd.
Beijing, N/A
Class II Ongoing
Z-1259-2025 MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Initiated 2025-01-31
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1242-2025 SIGNA MR355, SIGNA MR360, NMRI system
Initiated 2025-01-31
GE Healthcare (China) Co., Ltd.
Beijing, N/A
Class II Ongoing
Z-1308-2025 Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ…
Initiated 2025-01-31
Aesculap Inc
Center Valley, PA
Class II Ongoing
Z-1263-2025 MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Initiated 2025-01-31
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1255-2025 Paradigm REF: MMT-712 and MMT-715
Initiated 2025-01-31
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1309-2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann…
Initiated 2025-01-31
Aesculap Inc
Center Valley, PA
Class II Ongoing
Z-1258-2025 MiniMed insulin pump, REF: 620G (MMT-1750)
Initiated 2025-01-31
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1257-2025 Paradigm insulin pump, REF: MMT-754
Initiated 2025-01-31
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1260-2025 MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Initiated 2025-01-31
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1256-2025 Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
Initiated 2025-01-31
Medtronic MiniMed, Inc.
Northridge, CA
Class II Ongoing
Z-1247-2025 Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmw…
Initiated 2025-01-30
LEICA BIOSYSTEMS NUSSLOCH GMBH
Nussloch, N/A
Class II Ongoing
Z-1328-2025 Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Initiated 2025-01-29
Stryker Corporation
San Jose, CA
Class II Ongoing
Z-1238-2025 Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral device…
Initiated 2025-01-29
Pentax of America Inc
Montvale, NJ
Class II Ongoing
Z-1237-2025 PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic …
Initiated 2025-01-29
Pentax of America Inc
Montvale, NJ
Class II Ongoing
Z-1046-2025 Optima XR646 HD. X-Ray imaging system.
Initiated 2025-01-28
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1043-2025 Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Initiated 2025-01-28
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1045-2025 Discovery XR656 HD. X-Ray imaging system.
Initiated 2025-01-28
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1273-2025 ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthet…
Initiated 2025-01-27
Hiossen Inc.
Fairless Hills, PA
Class II Ongoing
Z-1274-2025 Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implan…
Initiated 2025-01-27
Hiossen Inc.
Fairless Hills, PA
Class II Ongoing
Z-1203-2025 Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
Initiated 2025-01-27
Dexcom, Inc.
San Diego, CA
Class II Ongoing
Z-1202-2025 Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Initiated 2025-01-27
Dexcom, Inc.
San Diego, CA
Class II Ongoing
Z-1271-2025 ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthet…
Initiated 2025-01-27
Hiossen Inc.
Fairless Hills, PA
Class II Ongoing
Z-1272-2025 ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthet…
Initiated 2025-01-27
Hiossen Inc.
Fairless Hills, PA
Class II Ongoing
Z-1275-2025 ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prostheti…
Initiated 2025-01-27
Hiossen Inc.
Fairless Hills, PA
Class II Ongoing
Z-1979-2025 Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM101020…
Initiated 2025-01-24
Guangzhou Pluslife Biotech Co., Ltd.
Guangzhou, N/A
Class II Ongoing
Z-1978-2025 Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Versio…
Initiated 2025-01-24
Guangzhou Pluslife Biotech Co., Ltd.
Guangzhou, N/A
Class II Ongoing
Z-1223-2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the dista…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1219-2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1224-2025 A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the di…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1222-2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal …
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1215-2025 A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixati…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1221-2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the dista…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1212-2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 77070806…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1213-2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1209-2025 A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fract…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1218-2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fr…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1226-2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the dista…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1210-2025 A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 77070804…
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1220-2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for …
Initiated 2025-01-21
Tyber Medical
Bethlehem, PA
Class II Ongoing
Z-1163-2025 Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic…
Initiated 2025-01-20
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-1164-2025 Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagn…
Initiated 2025-01-20
Microbiologics Inc
Saint Cloud, MN
Class II Ongoing
Z-1176-2025 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A…
Initiated 2025-01-17
KCI USA, INC.
San Antonio, TX
Class II Ongoing
Z-2463-2025 Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: P…
Initiated 2025-01-17
Zhejiang Luyao Electronics Technology Co., Ltd. Class II Ongoing
Z-1175-2025 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US P…
Initiated 2025-01-17
KCI USA, INC.
San Antonio, TX
Class II Ongoing
Z-1189-2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0…
Initiated 2025-01-16
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-1190-2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.…
Initiated 2025-01-16
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-1186-2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1…
Initiated 2025-01-16
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-1188-2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and …
Initiated 2025-01-16
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-1195-2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2…
Initiated 2025-01-16
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-1185-2025 Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0…
Initiated 2025-01-16
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-1187-2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.…
Initiated 2025-01-16
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-1192-2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.…
Initiated 2025-01-16
RAYSEARCH LABORATORIES AB
Stockholm, N/A
Class II Ongoing
Z-1248-2025 ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Initiated 2025-01-15
TERRAGENE S.A.
Alvear, N/A
Class II Ongoing
Z-1066-2025 Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitor…
Initiated 2025-01-14
Draeger Medical Systems, Inc.
Andover, MA
Class II Ongoing
Z-1087-2025 Azurion 3 M12 System Code: (1) 722063 (2) 722221
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-0183-2022 Ellume COVID-19 Home Test
Initiated 2021-10-01
ELLUME LTD
East Brisbane, N/A
Class I Ongoing
Z-1091-2025 Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1076-2025 Allura CV20 System Code: 722031
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1092-2025 Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1080-2025 AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1084-2025 AlluraXperFD20/10 System Code: (1) 722029
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1081-2025 AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1094-2025 Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 …
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1083-2025 AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1086-2025 AlluraXperFD20/15 System Code: (1) 722058
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1089-2025 Azurion 5 M12 System Code: (1) 722227 (2) 722231
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1078-2025 AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
Initiated 2025-01-13
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-1168-2025 Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Ve…
Initiated 2025-01-10
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-1269-2025 CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Initiated 2025-01-09
Kung Shin Plastics Co. Ltd. Class II Ongoing
Z-1268-2025 CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/C…
Initiated 2025-01-09
Kung Shin Plastics Co. Ltd. Class II Ongoing
Z-1095-2025 The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 7173…
Initiated 2025-01-08
Hologic, Inc.
San Diego, CA
Class II Ongoing
Z-1119-2025 (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES…
Initiated 2025-01-08
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-1227-2025 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI …
Initiated 2025-01-08
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-1229-2025 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2…
Initiated 2025-01-08
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-1039-2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Initiated 2025-01-06
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-1177-2025 Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) an…
Initiated 2025-01-03
XTANT Medical Holdings, Inc
Belgrade, MT
Class II Ongoing
Z-1114-2025 Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP12525…
Initiated 2025-01-02
US Endodontics, LLC
Johnson City, TN
Class II Ongoing
Z-1112-2025 Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Initiated 2025-01-02
Beckman Coulter Inc.
Brea, CA
Class II Ongoing
Z-1179-2025 AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Initiated 2024-12-23
Hollister Incorporated
Libertyville, IL
Class II Ongoing
Z-1180-2025 AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Initiated 2024-12-23
Hollister Incorporated
Libertyville, IL
Class II Ongoing
Z-1178-2025 AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Initiated 2024-12-23
Hollister Incorporated
Libertyville, IL
Class II Ongoing
Z-1030-2025 AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Initiated 2024-12-20
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1096-2025 PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general so…
Initiated 2024-12-20
Ethicon, LLC
San Lorenzo, PR
Class II Ongoing
Z-1034-2025 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Initiated 2024-12-20
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1036-2025 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Initiated 2024-12-20
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1011-2025 Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Initiated 2024-12-20
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1035-2025 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Initiated 2024-12-20
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1098-2025 ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Initiated 2024-12-20
Ethicon, LLC
San Lorenzo, PR
Class II Ongoing
Z-1025-2025 AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Initiated 2024-12-20
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1027-2025 AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Initiated 2024-12-20
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1018-2025 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalo…
Initiated 2024-12-20
Randox Laboratories, Limited Class II Ongoing
Z-1028-2025 AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Initiated 2024-12-20
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1024-2025 AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Initiated 2024-12-20
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1017-2025 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catal…
Initiated 2024-12-20
Randox Laboratories, Limited Class II Ongoing
Z-1009-2025 Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Initiated 2024-12-20
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-1055-2025 KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-1051-2025 KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-1052-2025 KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-1104-2025 Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Initiated 2024-12-19
New Medical Technologies Gmbh Class II Ongoing
Z-1057-2025 KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-1062-2025 KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-1004-2025 BD PCR Cartridges used with MAX System. Model Number: 437519
Initiated 2024-12-19
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-1053-2025 KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-1006-2025 Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certif…
Initiated 2024-12-19
Ortho-Clinical Diagnostics, INc.
Rochester, NY
Class II Ongoing
Z-1005-2025 Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified…
Initiated 2024-12-19
Ortho-Clinical Diagnostics, INc.
Rochester, NY
Class II Ongoing
Z-1007-2025 Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer…
Initiated 2024-12-19
Ortho-Clinical Diagnostics, INc.
Rochester, NY
Class II Ongoing
Z-1054-2025 KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-0924-2025 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wi…
Initiated 2024-12-19
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-0923-2025 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of proced…
Initiated 2024-12-19
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-1056-2025 KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-0768-2025 Bodor P and C series laser cutting machines
Initiated 2024-12-19
Jinan Bodor Cnc Machine Co Ltd Class II Ongoing
Z-1063-2025 KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Initiated 2024-12-19
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-0766-2025 EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Initiated 2024-12-18
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-1198-2025 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hyp…
Initiated 2024-12-16
Augustine Temperature Management, LLC
Minnetonka, MN
Class II Ongoing
Z-1197-2025 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypo…
Initiated 2024-12-16
Augustine Temperature Management, LLC
Minnetonka, MN
Class II Ongoing
Z-0977-2025 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides …
Initiated 2024-12-16
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-1015-2025 Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC…
Initiated 2024-12-13
Trinity Sterile, Inc.
Salisbury, MD
Class II Ongoing
Z-1012-2025 Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46…
Initiated 2024-12-13
Trinity Sterile, Inc.
Salisbury, MD
Class II Ongoing
Z-1014-2025 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicato…
Initiated 2024-12-13
Trinity Sterile, Inc.
Salisbury, MD
Class II Ongoing
Z-1013-2025 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 M…
Initiated 2024-12-13
Trinity Sterile, Inc.
Salisbury, MD
Class II Ongoing
Z-0984-2025 DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Initiated 2024-12-12
Medtronic Perfusion Systems
Brooklyn Park, MN
Class II Ongoing
Z-0761-2025 EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Initiated 2024-12-10
Encore Medical, LP
Austin, TX
Class II Ongoing
Z-0904-2025 Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) A…
Initiated 2024-12-10
ev3 Inc
Plymouth, MN
Class II Ongoing
Z-0918-2025 Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile …
Initiated 2024-12-06
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-0902-2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338…
Initiated 2024-12-05
QUIDEL ORTHO
Rochester, NY
Class II Ongoing
Z-1022-2025 Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 Th…
Initiated 2024-12-04
Medtronic Navigation, Inc.
Lafayette, CO
Class II Ongoing
Z-0946-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960;…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0936-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-263…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0931-2025 ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; …
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0939-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; …
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0943-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-411…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0927-2025 ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (trache…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0930-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0949-2025 ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; …
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0938-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-417…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0954-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-235…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0945-2025 ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, …
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0929-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0953-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0926-2025 ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 9…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0952-2025 ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A;…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0933-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-224…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0944-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; …
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0950-2025 Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO S…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0937-2025 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0932-2025 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-242…
Initiated 2024-12-03
Sklar Instruments
West Chester, PA
Class II Ongoing
Z-0845-2025 X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, …
Initiated 2024-12-02
Coloplast Manufacturing US, LLC
Minneapolis, MN
Class II Ongoing
Z-0958-2025 Change Healthcare Cardiology Hemo software
Initiated 2024-12-02
A L I Technologies Ltd Class II Ongoing
Z-0961-2025 VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Initiated 2024-12-02
Accriva Diagnostics, Inc.
San Diego, CA
Class II Ongoing
Z-0957-2025 McKesson Cardiology Hemo software
Initiated 2024-12-02
A L I Technologies Ltd Class II Ongoing
Z-0762-2025 MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Initiated 2024-12-02
Moximed, Inc.
Fremont, CA
Class II Ongoing
Z-0119-2022 Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical S…
Initiated 2021-08-19
Windstone Medical Packaging, Inc.
Billings, MT
Class I Ongoing
Z-0955-2025 OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, …
Initiated 2024-11-27
IsoTis OrthoBiologics, Inc.
Irvine, CA
Class II Ongoing
Z-0919-2025 OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Initiated 2024-11-27
IsoTis OrthoBiologics, Inc.
Irvine, CA
Class II Ongoing
Z-0803-2025 Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int…
Initiated 2024-11-26
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-0983-2025 Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Descript…
Initiated 2024-11-26
O&M HALYARD, INC.
Mechanicsville, VA
Class II Ongoing
Z-0996-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-…
Initiated 2024-11-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-1000-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a…
Initiated 2024-11-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0993-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front…
Initiated 2024-11-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0999-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a…
Initiated 2024-11-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0770-2025 AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Initiated 2024-11-25
Angiodynamics, Inc.
Queensbury, NY
Class II Ongoing
Z-1001-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-…
Initiated 2024-11-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0995-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-…
Initiated 2024-11-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0998-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a…
Initiated 2024-11-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0994-2025 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Gri…
Initiated 2024-11-25
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0966-2025 Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Initiated 2024-11-24
Adept Medical Ltd Class II Ongoing
Z-0964-2025 Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Initiated 2024-11-24
Adept Medical Ltd Class II Ongoing
Z-0969-2025 Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Initiated 2024-11-24
Adept Medical Ltd Class II Ongoing
Z-0965-2025 Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Initiated 2024-11-24
Adept Medical Ltd Class II Ongoing
Z-0967-2025 Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Initiated 2024-11-24
Adept Medical Ltd Class II Ongoing
Z-0736-2025 epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by tra…
Initiated 2024-11-22
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-0741-2025 epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by tra…
Initiated 2024-11-22
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-0743-2025 Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832…
Initiated 2024-11-22
3M Company - Health Care Business
Saint Paul, MN
Class II Ongoing
Z-0739-2025 epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by t…
Initiated 2024-11-22
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-0734-2025 epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by train…
Initiated 2024-11-22
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-0737-2025 epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by tra…
Initiated 2024-11-22
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-0778-2025 Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M…
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0792-2025 Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DY…
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0793-2025 Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM…
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0790-2025 See DocMan
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0791-2025 Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0773-2025 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL w…
Initiated 2024-11-21
Medtronic Neuromodulation
Minneapolis, MN
Class II Ongoing
Z-0779-2025 Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF,…
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0772-2025 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with …
Initiated 2024-11-21
Medtronic Neuromodulation
Minneapolis, MN
Class II Ongoing
Z-0777-2025 Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; …
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0753-2025 The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming …
Initiated 2024-11-21
Abbott Medical
Sylmar, CA
Class II Ongoing
Z-0786-2025 Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-…
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0789-2025 Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, R…
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0781-2025 Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
Initiated 2024-11-21
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0686-2025 Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Initiated 2024-11-20
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0776-2025 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Initiated 2024-11-19
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0802-2025 VACUETTE SAFELINK, REF: 450210
Initiated 2024-11-19
Greiner Bio-One GmbH Class II Ongoing
Z-0815-2025 Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Initiated 2024-11-18
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-0818-2025 Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Initiated 2024-11-18
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-1042-2025 Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Initiated 2024-11-18
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-1040-2025 Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUN…
Initiated 2024-11-18
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0583-2025 Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Initiated 2024-11-16
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0709-2025 mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Initiated 2024-11-15
Mint Medical GmbH Class II Ongoing
Z-0710-2025 mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Initiated 2024-11-15
Mint Medical GmbH Class II Ongoing
Z-0672-2025 BD Pyxis CII Safe ES, REF: 1116-00
Initiated 2024-11-14
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-0671-2025 BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
Initiated 2024-11-14
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-0670-2025 BD Pyxis MedStation ES, REF: 323
Initiated 2024-11-14
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-1326-2025 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Initiated 2024-11-13
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-0758-2025 ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Initiated 2024-11-12
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0767-2025 Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Initiated 2024-11-12
Siemens Healthcare Diagnostics, Inc.
Newark, DE
Class II Ongoing
Z-0808-2025 Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Initiated 2024-11-12
Aerin Medical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-0756-2025 ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Initiated 2024-11-12
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0757-2025 STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
Initiated 2024-11-12
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0755-2025 O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
Initiated 2024-11-12
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0676-2025 Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. …
Initiated 2024-11-11
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-0572-2025 TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Initiated 2024-11-11
Gauthier Biomedical, Inc.
Grafton, WI
Class II Ongoing
Z-1132-2025 Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA…
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-1126-2025 Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP …
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0910-2025 Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SC…
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0917-2025 Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Num…
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0914-2025 Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numb…
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0915-2025 Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog …
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-1128-2025 Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog N…
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0916-2025 Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS…
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-1131-2025 Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0908-2025 Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number …
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0728-2025 O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Initiated 2024-11-08
O&M HALYARD, INC.
Mechanicsville, VA
Class II Ongoing
Z-1133-2025 Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Ca…
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-1129-2025 Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTO…
Initiated 2024-11-08
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0725-2025 KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Initiated 2024-11-06
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0722-2025 SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
Initiated 2024-11-06
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0723-2025 Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU D…
Initiated 2024-11-06
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0719-2025 DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
Initiated 2024-11-06
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0718-2025 FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Initiated 2024-11-06
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0652-2025 ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment…
Initiated 2024-11-06
ICU Medical, Inc.
San Clemente, CA
Class II Ongoing
Z-0721-2025 Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU …
Initiated 2024-11-06
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0720-2025 Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17…
Initiated 2024-11-06
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0507-2025 V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an…
Initiated 2024-11-05
KCI USA, INC.
San Antonio, TX
Class II Ongoing
Z-0537-2025 dS Breast 16ch 1.5T
Initiated 2024-11-04
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0544-2025 Mammotrak Interventional Coil 3.0T
Initiated 2024-11-04
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0541-2025 Mammotrak Diagnostic Coil 1.5T
Initiated 2024-11-04
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0597-2025 Atellica CI Analyzer. Catalog Numbers: 10947347.
Initiated 2024-11-04
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-0540-2025 dS Breast 7ch 3.0T
Initiated 2024-11-04
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0548-2025 ST SENSE Breast Dx Coil
Initiated 2024-11-04
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0545-2025 SENSE Breast Coil
Initiated 2024-11-04
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0570-2025 Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Ari…
Initiated 2024-11-01
Securitas Healthcare LLC
Lincoln, NE
Class II Ongoing
Z-0675-2025 Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT658…
Initiated 2024-11-01
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0674-2025 Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Initiated 2024-11-01
Cardinal Health 200, LLC
Waukegan, IL
Class II Ongoing
Z-0589-2025 BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Initiated 2024-10-31
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0591-2025 BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Initiated 2024-10-31
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0590-2025 BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Initiated 2024-10-31
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0593-2025 BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Initiated 2024-10-31
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0598-2025 Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Initiated 2024-10-31
Cartiva, Inc
Alpharetta, GA
Class II Ongoing
Z-0584-2025 BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Initiated 2024-10-31
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0586-2025 BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Initiated 2024-10-31
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0596-2025 BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Initiated 2024-10-31
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-0751-2025 Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79…
Initiated 2024-10-29
SEASPINE ORTHOPEDICS CORPORATION
Carlsbad, CA
Class II Ongoing
Z-0581-2025 BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Initiated 2024-10-29
Smith & Nephew Inc.
Andover, MA
Class II Ongoing
Z-0530-2025 AMS Artificial Urinary Sphincter Control Pump
Initiated 2024-10-28
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-0531-2025 AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Initiated 2024-10-28
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-0519-2025 SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Initiated 2024-10-28
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-0517-2025 Discovery MR750w 3.0T, whole body magnetic resonance scanner
Initiated 2024-10-28
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-0518-2025 SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Initiated 2024-10-28
GE Medical Systems, LLC
Waukesha, WI
Class II Ongoing
Z-2403-2021 EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Initiated 2021-07-13
Micro Therapeutics Inc,
Irvine, CA
Class I Ongoing
Z-0679-2025 Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy S…
Initiated 2024-10-25
Noah Medical
San Carlos, CA
Class II Ongoing
Z-0550-2025 GE Proteus XR/A radiographic system
Initiated 2024-10-24
GE Healthcare (China) Co., Ltd. Class II Ongoing
Z-0355-2025 Lab Kit, SKU DYLAB1018; Component No. 503581
Initiated 2024-10-23
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0359-2025 URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Initiated 2024-10-23
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0354-2025 Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Initiated 2024-10-23
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0666-2025 MICRO-X Rover Mobile X-ray System, # MXU-RV19
Initiated 2024-10-23
Micro-X Ltd. Class II Ongoing
Z-0356-2025 UA KIT, SKU DYKM1690A; Component No. 503581
Initiated 2024-10-23
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0358-2025 URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 50…
Initiated 2024-10-23
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0363-2025 Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Initiated 2024-10-21
Karl Storz Endoscopy
El Segundo, CA
Class II Ongoing
Z-0599-2025 Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in h…
Initiated 2024-10-21
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-1251-2025 human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Initiated 2024-10-18
HUMAN MED AG Class II Ongoing
Z-0486-2025 Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Initiated 2024-10-16
Maquet Cardiovascular, LLC
Wayne, NJ
Class II Ongoing
Z-0513-2025 MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) T…
Initiated 2024-10-16
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0510-2025 MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STER…
Initiated 2024-10-16
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0511-2025 MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF…
Initiated 2024-10-16
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0485-2025 Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Initiated 2024-10-16
Maquet Cardiovascular, LLC
Wayne, NJ
Class II Ongoing
Z-0509-2025 MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND…
Initiated 2024-10-16
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-2537-2025 CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX o…
Initiated 2024-10-16
CORNEAT VISION, LTD.
Ra'Anana, N/A
Class II Ongoing
Z-0533-2025 (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ9…
Initiated 2024-10-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0532-2025 (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ90…
Initiated 2024-10-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0534-2025 Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Initiated 2024-10-15
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0554-2025 Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Initiated 2024-10-09
Shimadzu Corp. Analytical & Measuring Instruments Div. Class II Ongoing
Z-0632-2025 MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0623-2025 MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0624-2025 MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0639-2025 MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0645-2025 MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; …
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0636-2025 MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0625-2025 MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0640-2025 MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3)…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0339-2025 SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain…
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0335-2025 SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain…
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0344-2025 Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain …
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0637-2025 MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0330-2025 VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to conta…
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0342-2025 Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain …
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0634-2025 MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN P…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0643-2025 MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS9…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0644-2025 MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; …
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0622-2025 MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0647-2025 MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS9…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0332-2025 CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to conta…
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0337-2025 SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain …
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0646-2025 MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) M…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0626-2025 MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0343-2025 Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain …
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0635-2025 Refer to RES or lead review memo for complete list of affected reference/catalog numbers
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0628-2025 MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) OR…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0638-2025 MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0641-2025 MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MA…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0642-2025 MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYN…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0629-2025 MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, …
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0334-2025 CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to conta…
Initiated 2024-10-09
The Metrix Company
Dubuque, IA
Class II Ongoing
Z-0648-2025 MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATAR…
Initiated 2024-10-09
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0347-2025 Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-…
Initiated 2024-10-08
Cook Incorporated
Bloomington, IN
Class II Ongoing
Z-0921-2025 DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Initiated 2024-10-07
DRG International, Inc.
Springfield, NJ
Class II Ongoing
Z-0365-2025 Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appli…
Initiated 2024-10-04
Stryker Corporation
Portage, MI
Class II Ongoing
Z-0369-2025 Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgica…
Initiated 2024-10-04
Stryker Corporation
Portage, MI
Class II Ongoing
Z-0476-2025 Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Initiated 2024-10-04
Hobbs Medical, Inc.
Stafford Springs, CT
Class II Ongoing
Z-0367-2025 Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a…
Initiated 2024-10-04
Stryker Corporation
Portage, MI
Class II Ongoing
Z-0475-2025 Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Initiated 2024-10-04
Hobbs Medical, Inc.
Stafford Springs, CT
Class II Ongoing
Z-0366-2025 Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur…
Initiated 2024-10-04
Stryker Corporation
Portage, MI
Class II Ongoing
Z-0472-2025 Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Initiated 2024-10-04
Hobbs Medical, Inc.
Stafford Springs, CT
Class II Ongoing
Z-0349-2025 CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Initiated 2024-10-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0368-2025 Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosu…
Initiated 2024-10-04
Stryker Corporation
Portage, MI
Class II Ongoing
Z-0474-2025 Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Initiated 2024-10-04
Hobbs Medical, Inc.
Stafford Springs, CT
Class II Ongoing
Z-0471-2025 Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Initiated 2024-10-04
Hobbs Medical, Inc.
Stafford Springs, CT
Class II Ongoing
Z-0370-2025 Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgi…
Initiated 2024-10-04
Stryker Corporation
Portage, MI
Class II Ongoing
Z-0473-2025 Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Initiated 2024-10-04
Hobbs Medical, Inc.
Stafford Springs, CT
Class II Ongoing
Z-0462-2025 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a…
Initiated 2024-10-03
Getinge Usa Sales Inc
Wayne, NJ
Class II Ongoing
Z-0309-2025 DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Initiated 2024-10-03
DeRoyal Industries Inc
Powell, TN
Class II Ongoing
Z-0308-2025 DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Initiated 2024-10-03
DeRoyal Industries Inc
Powell, TN
Class II Ongoing
Z-0460-2025 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a…
Initiated 2024-10-03
Getinge Usa Sales Inc
Wayne, NJ
Class II Ongoing
Z-0458-2025 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a…
Initiated 2024-10-03
Getinge Usa Sales Inc
Wayne, NJ
Class II Ongoing
Z-0307-2025 DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Initiated 2024-10-03
DeRoyal Industries Inc
Powell, TN
Class II Ongoing
Z-0318-2025 GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2…
Initiated 2024-10-03
GE Healthcare
Chicago, IL
Class II Ongoing
Z-0463-2025 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a…
Initiated 2024-10-03
Getinge Usa Sales Inc
Wayne, NJ
Class II Ongoing
Z-0619-2025 MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 …
Initiated 2024-10-01
Advanced Medical Solutions Ltd. Class II Ongoing
Z-0617-2025 Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to he…
Initiated 2024-10-01
Advanced Medical Solutions Ltd. Class II Ongoing
Z-0618-2025 McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acu…
Initiated 2024-10-01
Advanced Medical Solutions Ltd. Class II Ongoing
Z-0464-2025 IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Initiated 2024-09-30
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-0467-2025 Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 …
Initiated 2024-09-30
Bard Peripheral Vascular Inc
Tempe, AZ
Class II Ongoing
Z-0269-2025 AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide pate…
Initiated 2024-09-26
King Systems Corp. dba Ambu, Inc.
Noblesville, IN
Class II Ongoing
Z-0270-2025 KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. …
Initiated 2024-09-26
King Systems Corp. dba Ambu, Inc.
Noblesville, IN
Class II Ongoing
Z-0276-2025 KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide paten…
Initiated 2024-09-26
King Systems Corp. dba Ambu, Inc.
Noblesville, IN
Class II Ongoing
Z-0274-2025 KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent …
Initiated 2024-09-26
King Systems Corp. dba Ambu, Inc.
Noblesville, IN
Class II Ongoing
Z-0286-2025 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Initiated 2024-09-24
Siemens Healthcare Diagnostics Inc
Norwood, MA
Class II Ongoing
Z-0808-2019 Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number …
Initiated 2019-01-17
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-2055-2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Initiated 2020-04-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2939-2020 BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346…
Initiated 2020-08-04
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-1544-2021 Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Initiated 2021-03-26
Infusion Pump Repair
Irvine, CA
Class I Ongoing
Z-1336-2021 Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN,…
Initiated 2021-02-26
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-1340-2021 Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Initiated 2021-02-26
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2909-2020 Alaris System PC Unit Model 8015
Initiated 2020-08-04
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-0955-2020 Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US an…
Initiated 2019-11-21
Medtronic Inc.
Northridge, CA
Class I Ongoing
Z-0958-2020 Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and M…
Initiated 2019-11-21
Medtronic Inc.
Northridge, CA
Class I Ongoing
Z-1928-2018 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-080…
Initiated 2018-05-03
Maquet Datascope Corp - Cardiac Assist Division
Mahwah, NJ
Class I Ongoing
Z-2882-2020 BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System…
Initiated 2020-08-04
CareFusion 303, Inc.
San Diego, CA
Class I Ongoing
Z-1339-2021 Medtronic HVAD Monitor Data Cable, Product Number: 1575
Initiated 2021-02-26
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2058-2020 Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Initiated 2020-04-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2056-2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Initiated 2020-04-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2020-2021 INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Initiated 2021-06-03
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-1726-2015 HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intende…
Initiated 2015-04-29
HeartWare Inc
Miami Lakes, FL
Class I Ongoing
Z-1427-2020 HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients wit…
Initiated 2020-01-23
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-0807-2019 Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) …
Initiated 2019-01-17
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1538-2017 HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-card…
Initiated 2017-02-03
Heartware
Miami Lakes, FL
Class I Ongoing
Z-0812-2019 vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1…
Initiated 2019-01-17
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mounds View, MN
Class I Ongoing
Z-1731-2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205.…
Initiated 2015-04-29
HeartWare Inc
Miami Lakes, FL
Class I Ongoing
Z-1428-2020 HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in pa…
Initiated 2020-01-23
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2057-2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Initiated 2020-04-03
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-0957-2020 Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed withi…
Initiated 2019-11-21
Medtronic Inc.
Northridge, CA
Class I Ongoing
Z-1337-2021 Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT…
Initiated 2021-02-26
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-1651-2021 Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA…
Initiated 2021-03-25
The Biomed Guys
Clarksville, TN
Class I Ongoing
Z-1338-2021 Medtronic HVAD Alarm Adapter, Product Number: 1450
Initiated 2021-02-26
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2019-2021 INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Initiated 2021-06-03
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-1341-2021 Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1…
Initiated 2021-02-26
Heartware, Inc.
Miami Lakes, FL
Class I Ongoing
Z-2016-2021 INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 …
Initiated 2021-06-03
Boston Scientific Corporation
Saint Paul, MN
Class I Ongoing
Z-0956-2020 Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-176…
Initiated 2019-11-21
Medtronic Inc.
Northridge, CA
Class I Ongoing
Z-0391-2025 Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0244-2025 SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use i…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0413-2025 Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0392-2025 Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0385-2025 Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0390-2025 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0454-2025 Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0394-2025 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0433-2025 Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0427-2025 Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0253-2025 SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in …
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0387-2025 Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0448-2025 Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0247-2025 SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in …
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0420-2025 Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0402-2025 Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0246-2025 SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in p…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0401-2025 Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0438-2025 Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0383-2025 Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0243-2025 SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the u…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0431-2025 Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0240-2025 SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0407-2025 Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0444-2025 Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0238-2025 SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0250-2025 SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in pr…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0248-2025 SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in pro…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0384-2025 Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0422-2025 Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0428-2025 Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0408-2025 Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0239-2025 SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0421-2025 Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0449-2025 Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0251-2025 SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in pro…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0393-2025 Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0254-2025 SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in prote…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0412-2025 Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0255-2025 SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in prote…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0443-2025 Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0426-2025 Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0455-2025 Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0409-2025 Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0414-2025 Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0395-2025 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0419-2025 Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0400-2025 Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0452-2025 Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0237-2025 SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use i…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0416-2025 Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0256-2025 SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in pr…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0453-2025 Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0430-2025 Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0241-2025 SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use i…
Initiated 2024-09-20
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0410-2025 Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0388-2025 Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0386-2025 Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
Initiated 2024-09-20
AVID Medical, Inc.
Toano, VA
Class II Ongoing
Z-0257-2025 Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-…
Initiated 2024-09-19
Covidien LP
Mansfield, MA
Class II Ongoing
Z-0228-2025 a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7…
Initiated 2024-09-18
Baxter Healthcare Corporation
Deerfield, IL
Class II Ongoing
Z-0498-2025 Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Numbe…
Initiated 2024-09-18
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0362-2025 The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and man…
Initiated 2024-09-17
Topcon Medical Systems, Inc.
Oakland, NJ
Class II Ongoing
Z-0285-2025 Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo…
Initiated 2024-09-17
Zimmer, Inc.
Warsaw, IN
Class II Ongoing
Z-0261-2025 Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Cat…
Initiated 2024-09-16
Ambu Inc.
Columbia, MD
Class II Ongoing
Z-0596-2024 Regard Dressing change kit, Item Number 800026006
Initiated 2023-11-20
ROi CPS LLC
Republic, MO
Class I Terminated
Z-0351-2025 Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Produ…
Initiated 2024-09-13
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0054-2025 MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) …
Initiated 2024-09-13
Integra LifeSciences Corp.
Princeton, NJ
Class II Ongoing
Z-0233-2025 Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF…
Initiated 2024-09-12
Abbott Molecular, Inc.
Des Plaines, IL
Class II Ongoing
Z-0234-2025 Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF …
Initiated 2024-09-12
Abbott Molecular, Inc.
Des Plaines, IL
Class II Ongoing
Z-0137-2025 SynchroMed II Infusion Pump. Product Number: 8637-20
Initiated 2024-09-11
Medtronic Neuromodulation
Minneapolis, MN
Class II Ongoing
Z-0364-2025 Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038…
Initiated 2024-09-11
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-3245-2024 LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Initiated 2024-09-11
Waldemar Link GmbH & Co. KG (Corp. Hq.) Class II Ongoing
Z-0024-2025 iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Initiated 2024-09-09
Atrium Medical Corporation
Merrimack, NH
Class II Ongoing
Z-0488-2025 EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo…
Initiated 2024-09-06
Enchroma Inc
Berkeley, CA
Class II Ongoing
Z-0055-2025 Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical…
Initiated 2024-09-06
Agfa Healthcare NV Class II Ongoing
Z-0316-2025 SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina…
Initiated 2024-09-06
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Kyoto, N/A
Class II Ongoing
Z-0105-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes a…
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0265-2025 Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The …
Initiated 2024-09-05
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-0096-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an …
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0043-2025 NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Initiated 2024-09-05
Luminex Molecular Diagnostics Inc Class II Ongoing
Z-0108-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive …
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0109-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive dis…
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0097-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an int…
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0104-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interacti…
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0101-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes a…
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0112-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an …
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0110-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an…
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0111-2025 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an…
Initiated 2024-09-05
Boston Scientific Corporation
Maple Grove, MN
Class II Ongoing
Z-0264-2025 Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Initiated 2024-09-04
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0088-2025 Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 149…
Initiated 2024-09-04
LEICA BIOSYSTEMS NUSSLOCH GMBH Class II Ongoing
Z-0175-2025 Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPA…
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0165-2025 Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, RE…
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0164-2025 Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b…
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0167-2025 Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0371-2025 The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur…
Initiated 2024-09-04
Bard Peripheral Vascular Inc
Tempe, AZ
Class II Ongoing
Z-0159-2025 Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0156-2025 Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PI…
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0151-2025 Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0180-2025 Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0085-2025 Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Initiated 2024-09-04
LEICA BIOSYSTEMS NUSSLOCH GMBH Class II Ongoing
Z-0172-2025 Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0179-2025 Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND…
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0178-2025 Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ223…
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0153-2025 Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK …
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0163-2025 Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0149-2025 Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0023-2025 Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications dur…
Initiated 2024-09-04
Howmedica Osteonics Corp.
Mahwah, NJ
Class II Ongoing
Z-0136-2025 bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound sy…
Initiated 2024-09-04
B-K Medical A/S
Herlev, N/A
Class II Ongoing
Z-0162-2025 Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0087-2025 Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501,…
Initiated 2024-09-04
LEICA BIOSYSTEMS NUSSLOCH GMBH Class II Ongoing
Z-0170-2025 Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0090-2025 Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 1…
Initiated 2024-09-04
LEICA BIOSYSTEMS NUSSLOCH GMBH Class II Ongoing
Z-0166-2025 Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICAT…
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0086-2025 Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sect…
Initiated 2024-09-04
LEICA BIOSYSTEMS NUSSLOCH GMBH Class II Ongoing
Z-0148-2025 Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0089-2025 Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 149…
Initiated 2024-09-04
LEICA BIOSYSTEMS NUSSLOCH GMBH Class II Ongoing
Z-0155-2025 Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH…
Initiated 2024-09-04
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-3195-2024 Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3197-2024 Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3196-2024 Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra o…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3193-2024 Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or sp…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3204-2024 SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3200-2024 Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra …
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3203-2024 SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images an…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3198-2024 Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3194-2024 Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of th…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-3205-2024 SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images a…
Initiated 2024-09-03
Philips North America Llc
Cambridge, MA
Class II Ongoing
Z-0062-2025 Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M…
Initiated 2024-08-30
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0061-2025 Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF…
Initiated 2024-08-30
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0034-2025 MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Initiated 2024-08-30
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0057-2025 Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3…
Initiated 2024-08-30
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0033-2025 MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Initiated 2024-08-30
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0060-2025 Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto…
Initiated 2024-08-30
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-3155-2024 stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the s…
Initiated 2024-08-29
Tornier, Inc
Bloomington, MN
Class II Ongoing
Z-3311-2024 Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia w…
Initiated 2024-08-29
CooperVision, Inc.
West Henrietta, NY
Class II Ongoing
Z-3209-2024 Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic…
Initiated 2024-08-29
Microcare Medical
Commerce City, CO
Class II Ongoing
Z-3310-2024 BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with asti…
Initiated 2024-08-29
CooperVision, Inc.
West Henrietta, NY
Class II Ongoing
Z-3309-2024 Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Initiated 2024-08-29
Tornier, Inc
Bloomington, MN
Class II Ongoing
Z-0123-2025 MEDLINE KIT CV I II, REF DYNJ906071B
Initiated 2024-08-28
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0122-2025 MEDLINE OPEN HEART, REF DYNJ904261B
Initiated 2024-08-28
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0121-2025 MEDLINE OPEN HEART PACK, REF DYNJ66216C
Initiated 2024-08-28
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0053-2025 Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Initiated 2024-08-28
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0119-2025 MEDLINE HEART CABG CDS, REF CDS983376R
Initiated 2024-08-28
MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL
Class II Ongoing
Z-0094-2025 The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatio…
Initiated 2024-08-28
Beckman Coulter, Inc.
Chaska, MN
Class II Ongoing
Z-3182-2024 HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Initiated 2024-08-27
Safeguard US Operating LLC
Harrisburg, NC
Class II Ongoing
Z-3181-2024 HAWK Warming Grid, Item Number: 59-300
Initiated 2024-08-27
Safeguard US Operating LLC
Harrisburg, NC
Class II Ongoing
Z-3183-2024 Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 5…
Initiated 2024-08-27
Safeguard US Operating LLC
Harrisburg, NC
Class II Ongoing
Z-0131-2025 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: …
Initiated 2024-08-26
Nova Ortho-Med Inc
Carson, CA
Class II Ongoing
Z-0129-2025 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description:…
Initiated 2024-08-26
Nova Ortho-Med Inc
Carson, CA
Class II Ongoing
Z-3210-2024 AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbod…
Initiated 2024-08-23
Stryker Spine
Allendale, NJ
Class II Ongoing
Z-0229-2025 Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Initiated 2024-08-23
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0050-2025 StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spin…
Initiated 2024-08-22
Medtronic Navigation, Inc.
Lafayette, CO
Class II Ongoing
Z-3303-2024 Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is emp…
Initiated 2024-08-22
Healgen Scientific Llc
Houston, TX
Class II Ongoing
Z-3165-2024 System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M…
Initiated 2024-08-22
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-3167-2024 System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allur…
Initiated 2024-08-22
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-0964-2026 da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Initiated 2024-08-21
Intuitive Surgical, Inc.
Sunnyvale, CA
Class II Ongoing
Z-0181-2025 Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Initiated 2024-08-21
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0127-2025 Horizon Cardiology Hemo. Version 12.2.
Initiated 2024-08-21
CHANGE HEALTHCARE CANADA COMPANY Class II Ongoing
Z-3305-2024 Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Initiated 2024-08-21
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-3184-2024 BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Initiated 2024-08-20
Cypress Medical Products LLC
Richmond, VA
Class II Ongoing
Z-0072-2025 basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Initiated 2024-08-19
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0070-2025 Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410…
Initiated 2024-08-19
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0071-2025 basixSKY Inflation Device, REF: SKY1802
Initiated 2024-08-19
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0069-2025 MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Initiated 2024-08-19
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0066-2025 DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Initiated 2024-08-19
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0064-2025 Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Initiated 2024-08-19
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-0029-2025 Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…
Initiated 2024-08-16
Windstone Medical Packaging, Inc.
Billings, MT
Class II Ongoing
Z-0030-2025 Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in…
Initiated 2024-08-16
Windstone Medical Packaging, Inc.
Billings, MT
Class II Ongoing
Z-0027-2025 Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in …
Initiated 2024-08-16
Windstone Medical Packaging, Inc.
Billings, MT
Class II Ongoing
Z-0031-2025 Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in …
Initiated 2024-08-16
Windstone Medical Packaging, Inc.
Billings, MT
Class II Ongoing
Z-0028-2025 Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged …
Initiated 2024-08-16
Windstone Medical Packaging, Inc.
Billings, MT
Class II Ongoing
Z-3140-2024 Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Initiated 2024-08-15
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-3173-2024 SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemod…
Initiated 2024-08-15
B Braun Medical Inc
Bethlehem, PA
Class II Ongoing
Z-3142-2024 Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Initiated 2024-08-15
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-3175-2024 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi…
Initiated 2024-08-15
B Braun Medical Inc
Bethlehem, PA
Class II Ongoing
Z-3174-2024 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi…
Initiated 2024-08-15
B Braun Medical Inc
Bethlehem, PA
Class II Ongoing
Z-3178-2024 STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during hae…
Initiated 2024-08-15
B Braun Medical Inc
Bethlehem, PA
Class II Ongoing
Z-3177-2024 STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model…
Initiated 2024-08-15
B Braun Medical Inc
Bethlehem, PA
Class II Ongoing
Z-3139-2024 Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Initiated 2024-08-15
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-3138-2024 Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Initiated 2024-08-15
CareFusion 303, Inc.
San Diego, CA
Class II Ongoing
Z-3169-2024 Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human…
Initiated 2024-08-15
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-3163-2024 TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fu…
Initiated 2024-08-14
Innovasis, Inc
Salt Lake City, UT
Class II Ongoing
Z-0134-2025 Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v…
Initiated 2024-08-13
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-3191-2024 Custom Procedure Kit, REF: K12T-11077
Initiated 2024-08-12
Merit Medical Systems, Inc.
South Jordan, UT
Class II Ongoing
Z-3097-2024 ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. …
Initiated 2024-08-12
Smith & Nephew Inc.
Andover, MA
Class II Ongoing
Z-3143-2024 Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video…
Initiated 2024-08-12
SEER MEDICAL PTY LTD Class II Ongoing
Z-1292-2025 Vios Monitoring System Bedside Monitor Model BSM2050
Initiated 2024-08-09
Murata Vios, Inc.
Woodbury, MN
Class II Ongoing
Z-0142-2025 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril…
Initiated 2024-08-09
Physio-Control, Inc.
Redmond, WA
Class II Ongoing
Z-3133-2024 Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-ce…
Initiated 2024-08-08
Zimmer GmbH Class II Ongoing
Z-2716-2024 Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722…
Initiated 2024-08-08
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-3146-2024 ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, …
Initiated 2024-08-08
GE Healthcare GmbH Class II Ongoing
Z-3244-2024 Pacemaker, COPM11B; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3261-2024 Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias…
Initiated 2024-08-07
Cook Biotech, Inc.
W Lafayette, IN
Class II Ongoing
Z-3237-2024 Hand Pack, AKHD97C; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3251-2024 Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi…
Initiated 2024-08-07
Cook Biotech, Inc.
W Lafayette, IN
Class II Ongoing
Z-3238-2024 Vaginal Delivery, ASDV25B; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-0044-2025 MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Initiated 2024-08-07
Howmedica Osteonics Corp.
Mahwah, NJ
Class II Ongoing
Z-3235-2024 IR Procedure Pack, CEAT19W; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3242-2024 Nasal Sinus Pack, MTSN26B; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3226-2024 PACEMAKER PACK, SLCV01J; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3236-2024 Neuro Vascular, ANKV91A; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3233-2024 Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3258-2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fis…
Initiated 2024-08-07
Cook Biotech, Inc.
W Lafayette, IN
Class II Ongoing
Z-3257-2024 Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal …
Initiated 2024-08-07
Cook Biotech, Inc.
W Lafayette, IN
Class II Ongoing
Z-3234-2024 Paracentesis Thoracente, SLPT76H; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3239-2024 Cath Lab Pack, CECL02P; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3227-2024 Endovascular AAA Pack, ESED52B; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3122-2024 FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Initiated 2024-08-07
BioFire Diagnostics, LLC
Salt Lake City, UT
Class II Ongoing
Z-3232-2024 Shoulder, SESH18I; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3260-2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fis…
Initiated 2024-08-07
Cook Biotech, Inc.
W Lafayette, IN
Class II Ongoing
Z-3243-2024 Cysto, FTCY03L; Medical convenience kit
Initiated 2024-08-07
American Contract Systems, Inc.
Kansas City, MO
Class II Ongoing
Z-3252-2024 Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi…
Initiated 2024-08-07
Cook Biotech, Inc.
W Lafayette, IN
Class II Ongoing
Z-2953-2024 Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number…
Initiated 2024-08-06
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Class II Ongoing
Z-2967-2024 ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-2957-2024 Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-2966-2024 Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-2964-2024 Pump 381 Pump Set (US); Product Code: 1000080;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-2961-2024 Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-2960-2024 Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-2969-2024 Impella CP Smart Assist Set; Product Code: 1000402;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-2970-2024 Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-2965-2024 Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Initiated 2024-08-05
Abiomed, Inc.
Danvers, MA
Class II Ongoing
Z-1995-2026 Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Initiated 2026-03-27
Straumann USA LLC
Andover, MA
Class II Ongoing
Z-1994-2026 Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutmen…
Initiated 2026-03-27
Straumann USA LLC
Andover, MA
Class II Ongoing
Z-0051-2025 Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M…
Initiated 2024-08-02
AURIS HEALTH INC
Redwood City, CA
Class II Ongoing
Z-3271-2024 WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inte…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3287-2024 AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Sys…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3284-2024 WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3279-2024 WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3277-2024 WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intende…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3246-2024 BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of …
Initiated 2024-08-01
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-3280-2024 WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3282-2024 WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3265-2024 WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3270-2024 WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3293-2024 AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3268-2024 WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3283-2024 WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3266-2024 WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intend…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3285-2024 WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3247-2024 BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically s…
Initiated 2024-08-01
Becton Dickinson & Co.
Sparks, MD
Class II Ongoing
Z-3290-2024 AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3267-2024 WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intend…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1937-2026 Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install…
Initiated 2026-03-24
Foundation Medicine, Inc.
Cambridge, MA
Class II Ongoing
Z-3278-2024 WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3276-2024 WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System …
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3275-2024 WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System I…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3274-2024 WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inte…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3286-2024 WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intende…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3295-2024 AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Sys…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-3273-2024 WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten…
Initiated 2024-08-01
Boston Scientific Corporation
Marlborough, MA
Class II Ongoing
Z-1854-2026 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Initiated 2026-03-23
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-0040-2025 Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Initiated 2024-07-31
Inspire Medical Systems Inc.
Golden Valley, MN
Class II Ongoing
Z-1851-2026 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Initiated 2026-03-23
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-3189-2024 Stainless Steel Sims Uterine Sound, Part Number 64-601
Initiated 2024-07-31
CooperSurgical, Inc.
Trumbull, CT
Class II Ongoing
Z-1853-2026 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Initiated 2026-03-23
Olympus Corporation of the Americas
Center Valley, PA
Class II Ongoing
Z-3065-2024 Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Initiated 2024-07-30
Siemens Healthcare Diagnostics, Inc.
Newark, DE
Class II Ongoing
Z-3063-2024 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Initiated 2024-07-29
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-2738-2024 DR 800. Digital Radiography X-ray System.
Initiated 2024-07-29
Agfa N.V. Class II Ongoing
Z-3064-2024 ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Initiated 2024-07-29
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
Class II Ongoing
Z-2008-2026 Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" …
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2037-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Nu…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2012-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2014-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2030-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2035-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medlin…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2023-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medlin…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2022-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline …
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2011-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2029-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2027-2026 Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, AC…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2038-2026 Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2034-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medli…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2009-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Num…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2006-2026 Brand Name: Leksell Vantage Arc System REF: 1053958
Initiated 2026-03-19
Elekta, Inc.
Atlanta, GA
Class II Ongoing
Z-2032-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline K…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2016-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medli…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2026-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2013-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit numb…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2020-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medli…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2018-2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT,…
Initiated 2026-03-19
Medline Industries, LP
Northfield, IL
Class II Ongoing
Z-2844-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2909-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2890-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2937-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2931-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2781-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-3100-2024 Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an…
Initiated 2024-07-26
Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
Class II Ongoing
Z-2896-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2888-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2877-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2928-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2875-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2843-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2860-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2892-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2876-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2913-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001775;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2847-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2852-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001200;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2800-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000192;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2906-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001712;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2887-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2891-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001622;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2822-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000759;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2924-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2911-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2893-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001629;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-2886-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing
Z-3299-2024 Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not …
Initiated 2024-07-26
ARROW INTERNATIONAL Inc.
Morrisville, NC
Class II Ongoing
Z-2927-2024 BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943;
Initiated 2024-07-26
Beaver Visitec International, Inc.
Waltham, MA
Class II Ongoing