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
| Recall # | Device | Manufacturer | Class | Status |
|---|---|---|---|---|
Z-1801-2026
|
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
|
B Braun Medical Inc
|
Class I | Ongoing |
Z-1797-2026
|
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
|
Insulet Corporation
|
Class I | Ongoing |
Z-1617-2026
|
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1616-2026
|
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1615-2026
|
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1647-2026
|
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1649-2026
|
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1719-2026
|
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
|
Medline Industries, LP
|
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; …
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1716-2026
|
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1714-2026
|
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1720-2026
|
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1728-2026
|
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1712-2026
|
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10M…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1718-2026
|
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1723-2026
|
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1722-2026
|
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1715-2026
|
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1588-2026
|
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
|
Navajo Manufacturing Company
|
Class I | Ongoing |
Z-1575-2026
|
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K…
|
Merit Medical Systems, Inc.
|
Class I | Ongoing |
Z-1576-2026
|
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, …
|
Merit Medical Systems, Inc.
|
Class I | Ongoing |
Z-1577-2026
|
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
|
Merit Medical Systems, Inc.
|
Class I | Ongoing |
Z-1579-2026
|
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96…
|
Merit Medical Systems, Inc.
|
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
|
Erbe USA Inc
|
Class I | Ongoing |
Z-1568-2026
|
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
|
Erbe USA Inc
|
Class I | Ongoing |
Z-1546-2026
|
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descripti…
|
Trividia Health, Inc.
|
Class I | Ongoing |
Z-1547-2026
|
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description…
|
Trividia Health, Inc.
|
Class I | Ongoing |
Z-1548-2026
|
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description…
|
Trividia Health, Inc.
|
Class I | Ongoing |
Z-1470-2026
|
Impella RP Flex with SmartAssist. Product Code: 1000323.
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-1469-2026
|
Impella RP with SmartAssist. Product Code: 0046-0035.
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-1471-2026
|
Impella RP. Product Code: 0046-0011.
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-1354-2026
|
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automat…
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-1353-2026
|
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa…
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-1320-2026
|
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1325-2026
|
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Syste…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1322-2026
|
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1161-2026
|
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1158-2026
|
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1163-2026
|
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1159-2026
|
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1115-2026
|
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve…
|
SunMed Holdings, LLC
|
Class I | Ongoing |
Z-0933-2026
|
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
|
Draeger, Inc.
|
Class I | Ongoing |
Z-0913-2026
|
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; …
|
GE Medical Systems China Co., Ltd. | Class I | Ongoing |
Z-1001-2026
|
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
|
AVID Medical, Inc.
|
Class I | Ongoing |
Z-1000-2026
|
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
|
AVID Medical, Inc.
|
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).…
|
Fresenius Kabi USA, LLC
|
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,…
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-0444-2026
|
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; V…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-0442-2026
|
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers:…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-0446-2026
|
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
|
Medline Industries, LP
|
Class I | Ongoing |
Z-0445-2026
|
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRON…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-0447-2026
|
Convenience Kit, BREAST HERNIA DYNJ909125G
|
Medline Industries, LP
|
Class I | Ongoing |
Z-0451-2026
|
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PA…
|
Medline Industries, LP
|
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…
|
Cerenovus Inc
|
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…
|
ICU Medical, Inc.
|
Class I | Ongoing |
Z-0069-2026
|
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding …
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-0161-2026
|
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
|
IMPRIS Imaging Inc
|
Class I | Ongoing |
Z-0164-2026
|
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
|
IMPRIS Imaging Inc
|
Class I | Ongoing |
Z-0070-2026
|
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M20…
|
B BRAUN MEDICAL INC
|
Class I | Ongoing |
Z-0373-2026
|
CODMAN Disposable Perforator 11mm. Cranial Perforator.
|
Integra LifeSciences Corp. (NeuroSciences)
|
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)…
|
Percussionaire Corporation
|
Class I | Ongoing |
Z-0136-2026
|
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect …
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-0065-2026
|
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
|
Olympus Corporation of the Americas
|
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 …
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-0067-2026
|
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0064-2026
|
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0047-2026
|
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0055-2026
|
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0046-2026
|
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0048-2026
|
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0062-2026
|
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0050-2026
|
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0059-2026
|
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0053-2026
|
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0056-2026
|
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0052-2026
|
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0045-2026
|
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-2660-2025
|
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1…
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2654-2025
|
Biograph mMR. Model Number: 10433372.
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2664-2025
|
MAGNETOM Verio. Model Number: 10276755.
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2658-2025
|
MAGNETOM Lumina (DE). Model Number: 11344916.
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2663-2025
|
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Numbe…
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2662-2025
|
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2667-2025
|
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693,…
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2668-2025
|
MAGNETOM Vida Fit. Model Number: 11410481.
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2661-2025
|
MAGNETOM Skyra fit. Model Number: 10849580.
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2656-2025
|
MAGNETOM Cima.X (DE). Model Number: 11647158.
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2666-2025
|
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
|
Siemens Medical Solutions USA, Inc
|
Class I | Ongoing |
Z-2670-2025
|
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
|
Medline Industries, LP
|
Class I | Ongoing |
Z-2481-2025
|
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
|
Medtronic Perfusion Systems
|
Class I | Ongoing |
Z-2484-2025
|
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device …
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-2482-2025
|
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
|
Medtronic Perfusion Systems
|
Class I | Ongoing |
Z-2610-2025
|
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-2611-2025
|
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbe…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-2612-2025
|
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic e…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-2446-2025
|
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe…
|
Dexcom, Inc.
|
Class I | Ongoing |
Z-2449-2025
|
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N…
|
Dexcom, Inc.
|
Class I | Ongoing |
Z-2326-2025
|
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model …
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2327-2025
|
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Mode…
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2448-2025
|
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe…
|
Dexcom, Inc.
|
Class I | Ongoing |
Z-2450-2025
|
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe…
|
Dexcom, Inc.
|
Class I | Ongoing |
Z-2343-2025
|
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen…
|
Tandem Diabetes Care, Inc.
|
Class I | Ongoing |
Z-2173-2025
|
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-2460-2025
|
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-2129-2025
|
Plum Duo Infusion System, List Number: 400020401
|
ICU Medical, Inc.
|
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…
|
Flexicare Medical (Dongguan) Ltd.
|
Class I | Ongoing |
Z-2184-2025
|
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
|
Flexicare Medical (Dongguan) Ltd.
|
Class I | Ongoing |
Z-2187-2025
|
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
|
Flexicare Medical (Dongguan) Ltd.
|
Class I | Ongoing |
Z-2185-2025
|
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
|
Flexicare Medical (Dongguan) Ltd.
|
Class I | Ongoing |
Z-2456-2025
|
IDM-MICRO-R. Electrical wheelchair component.
|
mo-Vis BVBA
|
Class I | Ongoing |
Z-2454-2025
|
Micro Joystick R-net. Electrical wheelchair component.
|
mo-Vis BVBA
|
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…
|
Ambu Inc.
|
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…
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-2228-2025
|
DreamStation Auto BiPAP. Non-Continuous Ventilator.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-2229-2025
|
DreamStation Auto. Non-Continuous Ventilator.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-2227-2025
|
DreamStation Auto CPAP. Non-Continuous Ventilator.
|
Philips Respironics, Inc.
|
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…
|
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…
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-2290-2025
|
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N…
|
Thoratec LLC
|
Class I | Ongoing |
Z-2158-2025
|
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
|
Draeger, Inc.
|
Class I | Ongoing |
Z-2159-2025
|
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
|
Draeger, Inc.
|
Class I | Ongoing |
Z-2161-2025
|
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
|
Draeger, Inc.
|
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…
|
Given Imaging Ltd.
|
Class I | Ongoing |
Z-2013-2025
|
Servo-u Ventilator System. Model Number: 6688600.
|
Maquet Critical Care AB | Class I | Ongoing |
Z-2014-2025
|
Servo-n Ventilator System. Model Number: 6694800.
|
Maquet Critical Care AB | Class I | Ongoing |
Z-1959-2025
|
Extended Tip Applicator, 15 CM, Box of 5.
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class I | Ongoing |
Z-1958-2025
|
Extended Tip Applicator, 8CM, Box of 5.
|
Integra LifeSciences Corp. (NeuroSciences)
|
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,…
|
Covidien
|
Class I | Ongoing |
Z-1904-2025
|
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36…
|
SunMed Holdings, LLC
|
Class I | Ongoing |
Z-2080-2025
|
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V…
|
Edwards Lifesciences, LLC
|
Class I | Ongoing |
Z-2083-2025
|
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A…
|
Edwards Lifesciences, LLC
|
Class I | Ongoing |
Z-2084-2025
|
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A …
|
Edwards Lifesciences, LLC
|
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-…
|
Dexcom, Inc.
|
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), …
|
Dexcom, Inc.
|
Class I | Ongoing |
Z-2037-2025
|
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric pa…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-2035-2025
|
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighin…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-2036-2025
|
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more…
|
Philips Respironics, Inc.
|
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…
|
Zyno Medical LLC
|
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…
|
Zyno Medical LLC
|
Class I | Ongoing |
Z-1717-2025
|
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
|
Integra LifeSciences Corp. (NeuroSciences)
|
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…
|
Medical Depot Inc.
|
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…
|
Smiths Medical ASD, Inc.
|
Class I | Ongoing |
Z-2483-2025
|
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
|
3M Company
|
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…
|
Smiths Medical ASD, Inc.
|
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…
|
Smiths Medical ASD, Inc.
|
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…
|
Smiths Medical ASD, Inc.
|
Class I | Ongoing |
Z-1662-2025
|
CADD Solis HSPCA Pump
|
Smiths Medical ASD, Inc.
|
Class I | Ongoing |
Z-1697-2025
|
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/…
|
Vyaire Medical
|
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.
|
Bausch & Lomb Surgical, Inc.
|
Class I | Ongoing |
Z-1625-2025
|
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1632-2025
|
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1636-2025
|
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1630-2025
|
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1627-2025
|
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1629-2025
|
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1633-2025
|
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1626-2025
|
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1638-2025
|
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1628-2025
|
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000
|
GE Medical Systems China Co., Ltd.
|
Class I | Ongoing |
Z-1528-2025
|
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Pr…
|
Avanos Medical, Inc.
|
Class I | Ongoing |
Z-1521-2025
|
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product D…
|
Avanos Medical, Inc.
|
Class I | Ongoing |
Z-1523-2025
|
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product…
|
Avanos Medical, Inc.
|
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…
|
Thoratec LLC
|
Class I | Ongoing |
Z-1493-2025
|
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable …
|
Draeger, Inc.
|
Class I | Ongoing |
Z-1495-2025
|
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software…
|
Draeger, Inc.
|
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…
|
Smiths Medical ASD, Inc.
|
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 …
|
Medtronic Perfusion Systems
|
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: …
|
Bard Peripheral Vascular Inc
|
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…
|
Micro Therapeutics, Inc.
|
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…
|
Micro Therapeutics, Inc.
|
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…
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-1145-2025
|
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1154-2025
|
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1151-2025
|
Allura CV20; Catalog numbers: 722031
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1160-2025
|
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1153-2025
|
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1144-2025
|
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1146-2025
|
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1149-2025
|
Allura Xper FD20/15; Catalog numbers: 722058
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1155-2025
|
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1147-2025
|
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class I | Ongoing |
Z-1070-2025
|
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,…
|
Spectranetics Corporation
|
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
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-0960-2025
|
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single P…
|
Percussionaire Corporation
|
Class I | Ongoing |
Z-0884-2025
|
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0887-2025
|
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0905-2025
|
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is design…
|
Olympus Corporation of the Americas
|
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,…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0830-2025
|
Impella RP Flex with SmartAssist; Product Number: 1000323;
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-0826-2025
|
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0821-2025
|
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 105…
|
Mercury Enterprises, Inc. dba Mercury Medical
|
Class I | Ongoing |
Z-0681-2025
|
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati…
|
Nova Biomedical Corporation
|
Class I | Ongoing |
Z-0683-2025
|
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ket…
|
Nova Biomedical Corporation
|
Class I | Ongoing |
Z-0660-2025
|
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Micro…
|
Kirwan Surgical Products, LLC
|
Class I | Ongoing |
Z-0658-2025
|
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Micros…
|
Kirwan Surgical Products, LLC
|
Class I | Ongoing |
Z-0655-2025
|
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The D…
|
Kirwan Surgical Products, LLC
|
Class I | Ongoing |
Z-0657-2025
|
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar …
|
Kirwan Surgical Products, LLC
|
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…
|
Medtronic Neurosurgery
|
Class I | Ongoing |
Z-0373-2025
|
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0375-2025
|
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0377-2025
|
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0379-2025
|
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0378-2025
|
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0305-2025
|
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Componen…
|
Draeger Medical, Inc.
|
Class I | Ongoing |
Z-0304-2025
|
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:…
|
Draeger Medical, Inc.
|
Class I | Ongoing |
Z-0328-2025
|
BioZorb Marker. Radiographic soft tissue marker.
|
Hologic, Inc
|
Class I | Ongoing |
Z-0292-2025
|
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediat…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-0293-2025
|
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-0294-2025
|
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult pat…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-0310-2025
|
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0092-2025
|
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
|
Maquet Cardiovascular, LLC
|
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…
|
Zyno Medical LLC
|
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…
|
Baxter Healthcare Corporation
|
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…
|
Fresenius Kabi USA, LLC
|
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…
|
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…
|
Percussionaire Corporation
|
Class I | Ongoing |
Z-3207-2024
|
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
|
Percussionaire Corporation
|
Class I | Ongoing |
Z-1947-2026
|
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits …
|
North American Rescue LLC.
|
Class I | Ongoing |
Z-1771-2026
|
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VA…
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1770-2026
|
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as…
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2690-2024
|
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati…
|
Breas Medical, Inc.
|
Class I | Ongoing |
Z-2587-2024
|
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thromb…
|
Inari Medical - Oak Canyon
|
Class I | Ongoing |
Z-2944-2024
|
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-2943-2024
|
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-0083-2025
|
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat…
|
Datex-Ohmeda, Inc.
|
Class I | Ongoing |
Z-0075-2025
|
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to…
|
Datex-Ohmeda, Inc.
|
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…
|
Datex-Ohmeda, Inc.
|
Class I | Ongoing |
Z-0082-2025
|
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to p…
|
Datex-Ohmeda, Inc.
|
Class I | Ongoing |
Z-0081-2025
|
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patie…
|
Datex-Ohmeda, Inc.
|
Class I | Ongoing |
Z-0074-2025
|
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to…
|
Datex-Ohmeda, Inc.
|
Class I | Ongoing |
Z-2636-2024
|
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
|
Covidien
|
Class I | Ongoing |
Z-1589-2026
|
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat…
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-1591-2026
|
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller…
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-2249-2024
|
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient …
|
Megadyne Medical Products, Inc.
|
Class I | Ongoing |
Z-2251-2024
|
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
|
Synergetics Inc
|
Class I | Ongoing |
Z-2252-2024
|
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
|
Synergetics Inc
|
Class I | Ongoing |
Z-2254-2024
|
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye…
|
Synergetics Inc
|
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…
|
Philips North America Llc
|
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…
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-2140-2024
|
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes …
|
Baxter Healthcare Corporation
|
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…
|
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…
|
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…
|
ICU Medical Inc
|
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…
|
ZOLL Medical Corporation
|
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
|
ARROW INTERNATIONAL Inc.
|
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
|
ARROW INTERNATIONAL Inc.
|
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
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-1811-2024
|
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
|
OptumHealth Care Solutions LLC
|
Class I | Ongoing |
Z-2443-2024
|
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, P…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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 …
|
Vyaire Medical, Inc.
|
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 …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1015-2026
|
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1014-2026
|
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1016-2026
|
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
|
Medline Industries, LP
|
Class I | Ongoing |
Z-1012-2026
|
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
|
Medline Industries, LP
|
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…
|
Abbott Diabetes Care, Inc.
|
Class I | Ongoing |
Z-1817-2024
|
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1812-2024
|
BiPAP V30 Auto Ventilator, Part Number 1111178
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1813-2024
|
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1814-2024
|
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-0885-2026
|
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients…
|
Fresenius Kabi USA, LLC
|
Class I | Ongoing |
Z-0593-2026
|
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the …
|
Draeger, Inc.
|
Class I | Ongoing |
Z-0591-2026
|
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the b…
|
Draeger, Inc.
|
Class I | Ongoing |
Z-0590-2026
|
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the brea…
|
Draeger, Inc.
|
Class I | Ongoing |
Z-1505-2024
|
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1501-2024
|
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
|
Philips Respironics, Inc.
|
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)
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1503-2024
|
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1733-2024
|
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ…
|
Hologic, Inc
|
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…
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-1609-2024
|
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
|
Tandem Diabetes Care, Inc.
|
Class I | Ongoing |
Z-1355-2024
|
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
|
SleepNet Corporation
|
Class I | Ongoing |
Z-1692-2024
|
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
|
Thoratec Corp.
|
Class I | Ongoing |
Z-1356-2024
|
iQ 2 Nasal Vented Mask
|
SleepNet Corporation
|
Class I | Ongoing |
Z-1354-2024
|
Mojo 2 Full Face Non Vented Mask, All Sizes
|
SleepNet Corporation
|
Class I | Ongoing |
Z-1352-2024
|
Mojo Non Vented Full Face Mask with Headgear, All Sizes
|
SleepNet Corporation
|
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 …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-0488-2026
|
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
|
TMJ Solutions Inc
|
Class I | Ongoing |
Z-1301-2024
|
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigationa…
|
Thoratec Corp.
|
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…
|
Thoratec Corp.
|
Class I | Ongoing |
Z-0532-2026
|
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PT…
|
Glycar SA Pty., Ltd.
|
Class I | Ongoing |
Z-1274-2024
|
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-1275-2024
|
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-0188-2026
|
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09…
|
BALT USA, LLC
|
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…
|
Cook Medical Incorporated
|
Class I | Ongoing |
Z-1324-2024
|
stay-safe /Luer Lock Adapter 4 in
|
Fresenius Medical Care Holdings, Inc.
|
Class I | Ongoing |
Z-1326-2024
|
stay-safe /Luer Lock Catheter Ext. 18 in
|
Fresenius Medical Care Holdings, Inc.
|
Class I | Ongoing |
Z-1327-2024
|
stay-safe /Luer Catheter Ext. 6 in
|
Fresenius Medical Care Holdings, Inc.
|
Class I | Ongoing |
Z-1162-2024
|
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used …
|
Medtronic Neurosurgery
|
Class I | Ongoing |
Z-1163-2024
|
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used…
|
Medtronic Neurosurgery
|
Class I | Ongoing |
Z-1166-2024
|
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile E…
|
Medtronic Neurosurgery
|
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
|
Abbott
|
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
|
Abbott
|
Class I | Ongoing |
Z-0109-2026
|
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
|
Abbott
|
Class I | Ongoing |
Z-0028-2026
|
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
|
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…
|
Draeger, Inc.
|
Class I | Ongoing |
Z-2617-2025
|
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product …
|
Draeger, Inc.
|
Class I | Ongoing |
Z-1186-2024
|
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connec…
|
Avanos Medical, Inc.
|
Class I | Ongoing |
Z-1187-2024
|
MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit -…
|
Avanos Medical, Inc.
|
Class I | Ongoing |
Z-1062-2024
|
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
|
Vyaire Medical
|
Class I | Ongoing |
Z-1064-2024
|
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
|
Vyaire Medical
|
Class I | Ongoing |
Z-1061-2024
|
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
|
Vyaire Medical
|
Class I | Ongoing |
Z-1060-2024
|
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
|
Vyaire Medical
|
Class I | Ongoing |
Z-1059-2024
|
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
|
Vyaire Medical
|
Class I | Ongoing |
Z-1063-2024
|
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
|
Vyaire Medical
|
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…
|
Dexcom, Inc.
|
Class I | Ongoing |
Z-0842-2024
|
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. …
|
Thoratec Corp.
|
Class I | Ongoing |
Z-0089-2026
|
Model Number L211 PROPONENT DR SL MRI Pacemaker
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0099-2026
|
Model Number S702, ALTRUA 2 DR SL Pacemaker
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0102-2026
|
Model Number U128, VALITUDE CRT-P EL MRI
|
Boston Scientific Corporation
|
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…
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-0091-2026
|
Model Number L231, PROPONENT DR EL MRI Pacemaker
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0093-2026
|
Model Number L101, ESSENTIO DR SL Pacemaker
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0087-2026
|
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0104-2026
|
Model Number U226, VISIONIST CRT-P EL
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0085-2026
|
PROPONENT SR SL (Model L200)
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0105-2026
|
Model Number U228, VISIONIST CRT-P EL MRI
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0090-2026
|
Model Number L221 PROPONENT DR EL Pacemaker
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0097-2026
|
Model Number L131, ESSENTIO DR EL MRI Pacemaker
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0084-2026
|
ACCOLADE DR EL MRI (Model L331)
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0096-2026
|
Model Number L121 ESSENTIO DR EL Pacemaker
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0858-2024
|
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0849-2024
|
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0855-2024
|
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0854-2024
|
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0847-2024
|
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0852-2024
|
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0851-2024
|
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0848-2024
|
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0980-2024
|
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Cod…
|
Abiomed, Inc.
|
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…
|
Max Mobility LLC
|
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…
|
Max Mobility LLC
|
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…
|
Max Mobility LLC
|
Class I | Ongoing |
Z-0864-2024
|
smiths medical Medfusion Model 4000 syringe pump
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2593-2025
|
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class I | Ongoing |
Z-0929-2024
|
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4…
|
Philips North America
|
Class I | Ongoing |
Z-0931-2024
|
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074…
|
Philips North America
|
Class I | Ongoing |
Z-0930-2024
|
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292…
|
Philips North America
|
Class I | Ongoing |
Z-2333-2025
|
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0710-2024
|
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
|
Maquet Cardiovascular, LLC
|
Class I | Ongoing |
Z-2332-2025
|
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0600-2024
|
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M…
|
Megadyne Medical Products, Inc.
|
Class I | Ongoing |
Z-2431-2025
|
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal …
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2435-2025
|
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transsepta…
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2432-2025
|
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal …
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2429-2025
|
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal …
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2427-2025
|
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal…
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2430-2025
|
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal …
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2566-2025
|
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATI…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
Insulet Corporation
|
Class I | Ongoing |
Z-0594-2024
|
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
|
Busse Hospital Disposables, Inc.
|
Class I | Ongoing |
Z-0538-2024
|
AirTouch F20 Full Face Mask and User Guide
|
ResMed Ltd.
|
Class I | Ongoing |
Z-0540-2024
|
AirTouch N20 Nasal Mask and User Guide
|
ResMed Ltd.
|
Class I | Ongoing |
Z-0541-2024
|
AirFit F30 Full Face Mask and User Guide
|
ResMed Ltd.
|
Class I | Ongoing |
Z-0536-2024
|
AirFit N10 Nasal Masks and User Guide
|
ResMed Ltd.
|
Class I | Ongoing |
Z-2176-2025
|
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
|
B BRAUN MEDICAL INC
|
Class I | Ongoing |
Z-1090-2024
|
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1124-2024
|
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1123-2024
|
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF …
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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; …
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1104-2024
|
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1108-2024
|
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1129-2024
|
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1106-2024
|
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1126-2024
|
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1103-2024
|
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1112-2024
|
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT2121…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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 …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1138-2024
|
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
|
MEDLINE INDUSTRIES, LP - Northfield
|
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, …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1100-2024
|
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1110-2024
|
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1131-2024
|
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
Nurse Assist, LLC
|
Class I | Ongoing |
Z-0355-2024
|
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3…
|
B. Braun Medical, Inc.
|
Class I | Ongoing |
Z-2095-2025
|
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-2096-2025
|
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-2102-2025
|
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngosc…
|
Intersurgical Inc
|
Class I | Ongoing |
Z-0561-2024
|
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-0194-2024
|
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0193-2024
|
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
|
Olympus Corporation of the Americas
|
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…
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0191-2024
|
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0192-2024
|
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model…
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0233-2024
|
VariSoft infusion set, Model Number 1002828
|
Unomedical A/S
|
Class I | Ongoing |
Z-0075-2024
|
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-0123-2024
|
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
|
B. Braun Medical, Inc.
|
Class I | Ongoing |
Z-0124-2024
|
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
|
B. Braun Medical, Inc.
|
Class I | Ongoing |
Z-0145-2024
|
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
|
Cardinal Health 200, LLC
|
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…
|
Fresenius Kabi USA, LLC
|
Class I | Ongoing |
Z-0148-2024
|
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0150-2024
|
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0147-2024
|
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0146-2024
|
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0186-2024
|
Alaris PCA Module 8120
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-0185-2024
|
BD Alaris Syringe Module, REF 8110
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-0111-2024
|
Astral 100 and Astral 150 ventilators
|
ResMed Ltd.
|
Class I | Ongoing |
Z-0094-2024
|
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF…
|
EITAN MEDICAL LTD
|
Class I | Ongoing |
Z-0034-2024
|
2008T HD SYS. W/O CDX BLUESTAR
|
Fresenius Medical Care Holdings, Inc.
|
Class I | Ongoing |
Z-0028-2024
|
2008T Hemodialysis SYS, with CDX
|
Fresenius Medical Care Holdings, Inc.
|
Class I | Ongoing |
Z-0035-2024
|
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
|
Fresenius Medical Care Holdings, Inc.
|
Class I | Ongoing |
Z-1767-2025
|
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
|
Baxter Healthcare Corporation
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1810-2025
|
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1759-2025
|
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
|
C.R. Bard Inc
|
Class I | Ongoing |
Z-1758-2025
|
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
|
C.R. Bard Inc
|
Class I | Ongoing |
Z-1760-2025
|
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl…
|
Centerline Biomedical Inc
|
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; …
|
Baxter Healthcare Corporation
|
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
|
Fresenius Medical Care Holdings, Inc.
|
Class I | Ongoing |
Z-0006-2024
|
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
|
Fresenius Medical Care Holdings, Inc.
|
Class I | Ongoing |
Z-2514-2023
|
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
Datascope Corp.
|
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…
|
Datascope Corp.
|
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…
|
Datascope Corp.
|
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
|
Datascope Corp.
|
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
|
Datascope Corp.
|
Class I | Ongoing |
Z-2529-2023
|
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-2526-2023
|
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-2528-2023
|
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-2525-2023
|
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-2530-2023
|
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-2527-2023
|
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-1585-2025
|
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product …
|
Conavi Medical Inc.
|
Class I | Ongoing |
Z-2507-2023
|
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is a…
|
Abbott Medical
|
Class I | Ongoing |
Z-2505-2023
|
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product …
|
Abbott Medical
|
Class I | Ongoing |
Z-2510-2023
|
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an ele…
|
Abbott Medical
|
Class I | Ongoing |
Z-2511-2023
|
Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an ele…
|
Abbott Medical
|
Class I | Ongoing |
Z-1533-2025
|
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (C…
|
ZOLL Circulation, Inc.
|
Class I | Ongoing |
Z-2248-2023
|
Carina Sub-Acute Care Ventilator
|
Draeger Medical, Inc.
|
Class I | Ongoing |
Z-1519-2025
|
t:slim X2 Insulin Pump with Interoperable Technology
|
Tandem Diabetes Care, Inc.
|
Class I | Ongoing |
Z-1390-2025
|
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
|
Covidien
|
Class I | Ongoing |
Z-1457-2025
|
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class I | Ongoing |
Z-1304-2025
|
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-2372-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200…
|
Covidien LP
|
Class I | Ongoing |
Z-2388-2023
|
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
|
Covidien LP
|
Class I | Ongoing |
Z-2391-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 88883…
|
Covidien LP
|
Class I | Ongoing |
Z-2383-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
|
Covidien LP
|
Class I | Ongoing |
Z-2371-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 888810200…
|
Covidien LP
|
Class I | Ongoing |
Z-2384-2023
|
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
|
Covidien LP
|
Class I | Ongoing |
Z-2379-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
|
Covidien LP
|
Class I | Ongoing |
Z-2390-2023
|
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
|
Covidien LP
|
Class I | Ongoing |
Z-2376-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104…
|
Covidien LP
|
Class I | Ongoing |
Z-2369-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003H…
|
Covidien LP
|
Class I | Ongoing |
Z-2378-2023
|
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
|
Covidien LP
|
Class I | Ongoing |
Z-2380-2023
|
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
|
Covidien LP
|
Class I | Ongoing |
Z-2373-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 888810300…
|
Covidien LP
|
Class I | Ongoing |
Z-2374-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 888810300…
|
Covidien LP
|
Class I | Ongoing |
Z-2377-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104…
|
Covidien LP
|
Class I | Ongoing |
Z-2382-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
|
Covidien LP
|
Class I | Ongoing |
Z-2386-2023
|
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
|
Covidien LP
|
Class I | Ongoing |
Z-2368-2023
|
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002H…
|
Covidien LP
|
Class I | Ongoing |
Z-1286-2025
|
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
|
Smiths Medical ASD, Inc.
|
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.…
|
Smiths Medical ASD, Inc.
|
Class I | Ongoing |
Z-1285-2025
|
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.…
|
Smiths Medical ASD, Inc.
|
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…
|
Smiths Medical ASD, Inc.
|
Class I | Ongoing |
Z-1282-2025
|
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.…
|
Smiths Medical ASD, Inc.
|
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…
|
Smiths Medical ASD, Inc.
|
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
|
Smiths Medical ASD, Inc.
|
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…
|
Smiths Medical ASD, Inc.
|
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…
|
Smiths Medical ASD, Inc.
|
Class I | Ongoing |
Z-2104-2023
|
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-2113-2023
|
Impella LD intravascular micro axial blood pump, Product Number 005082
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-2112-2023
|
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-2116-2023
|
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-2018-2023
|
Oxylog 3000 Plus emergency and transport ventilator
|
Draeger Medical, Inc.
|
Class I | Ongoing |
Z-2012-2023
|
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-2017-2023
|
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-2015-2023
|
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-2014-2023
|
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
|
Olympus Corporation of the Americas
|
Class I | Ongoing |
Z-2011-2023
|
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
|
Olympus Corporation of the Americas
|
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…
|
Datascope Corp.
|
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
|
Datascope Corp.
|
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…
|
Datascope Corp.
|
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
|
Datascope Corp.
|
Class I | Ongoing |
Z-2001-2023
|
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
|
Megadyne Medical Products, Inc.
|
Class I | Ongoing |
Z-1999-2023
|
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
|
Megadyne Medical Products, Inc.
|
Class I | Ongoing |
Z-1997-2023
|
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
|
Megadyne Medical Products, Inc.
|
Class I | Ongoing |
Z-1994-2023
|
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
|
Megadyne Medical Products, Inc.
|
Class I | Ongoing |
Z-1995-2023
|
MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
|
Megadyne Medical Products, Inc.
|
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…
|
Getinge Usa Sales Inc
|
Class I | Ongoing |
Z-1834-2023
|
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1875-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1937-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1889-2023
|
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1905-2023
|
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1922-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1892-2023
|
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1933-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1896-2023
|
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1959-2023
|
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1869-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1930-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1949-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1926-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1841-2023
|
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1945-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1901-2023
|
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1872-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1883-2023
|
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1827-2023
|
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1833-2023
|
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1835-2023
|
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1877-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1830-2023
|
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1888-2023
|
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1865-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1886-2023
|
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1954-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1897-2023
|
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1957-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1874-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1958-2023
|
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1829-2023
|
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1839-2023
|
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1847-2023
|
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1858-2023
|
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1859-2023
|
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1871-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1887-2023
|
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1880-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1873-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1923-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1932-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1963-2023
|
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1867-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1931-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1842-2023
|
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1925-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1868-2023
|
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180065
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1948-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1836-2023
|
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1939-2023
|
Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1844-2023
|
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1944-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1950-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1837-2023
|
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1940-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1890-2023
|
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1941-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1962-2023
|
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1899-2023
|
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1884-2023
|
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1852-2023
|
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1953-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1946-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1881-2023
|
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1956-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1846-2023
|
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1960-2023
|
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1942-2023
|
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780045
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1851-2023
|
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
|
TELEFLEX LLC
|
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…
|
Fresenius Kabi USA, LLC
|
Class I | Ongoing |
Z-1826-2023
|
ARROW Endurance Extended Dwell Peripheral Catheter System
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-1707-2023
|
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1715-2023
|
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1722-2023
|
ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1746-2023
|
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1739-2023
|
CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1732-2023
|
CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1786-2023
|
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1757-2023
|
CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1769-2023
|
CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1762-2023
|
CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1793-2023
|
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1752-2023
|
CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1780-2023
|
ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1708-2023
|
ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1822-2023
|
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1729-2023
|
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1773-2023
|
CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1817-2023
|
ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1805-2023
|
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1808-2023
|
ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1718-2023
|
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1744-2023
|
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1800-2023
|
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1749-2023
|
CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1809-2023
|
ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1720-2023
|
ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1755-2023
|
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1811-2023
|
ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1797-2023
|
ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1798-2023
|
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1717-2023
|
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1787-2023
|
CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1794-2023
|
ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1754-2023
|
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1814-2023
|
ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1728-2023
|
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1705-2023
|
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1777-2023
|
CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1704-2023
|
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1714-2023
|
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1799-2023
|
ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1807-2023
|
ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1767-2023
|
CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1796-2023
|
ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1734-2023
|
CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1781-2023
|
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1782-2023
|
CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1731-2023
|
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1772-2023
|
CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1795-2023
|
ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1713-2023
|
ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1745-2023
|
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1771-2023
|
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1721-2023
|
ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1763-2023
|
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1723-2023
|
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1804-2023
|
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1803-2023
|
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1770-2023
|
CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1725-2023
|
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1785-2023
|
CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1727-2023
|
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1815-2023
|
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1740-2023
|
CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1783-2023
|
CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1758-2023
|
CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1753-2023
|
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1765-2023
|
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1812-2023
|
ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1802-2023
|
ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1742-2023
|
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1741-2023
|
CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1735-2023
|
CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1736-2023
|
CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1816-2023
|
ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1748-2023
|
CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1818-2023
|
ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1719-2023
|
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1716-2023
|
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1778-2023
|
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1759-2023
|
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1047-2025
|
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to …
|
ROi CPS LLC
|
Class I | Ongoing |
Z-1651-2023
|
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, …
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1649-2023
|
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110…
|
Philips Respironics, Inc.
|
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…
|
Max Mobility LLC
|
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…
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-0763-2025
|
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
|
Fresenius Kabi USA, LLC
|
Class I | Ongoing |
Z-1630-2023
|
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
|
Medtronic Navigation, Inc.
|
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…
|
Cook Incorporated
|
Class I | Ongoing |
Z-0715-2025
|
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
|
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)…
|
Cook Incorporated
|
Class I | Ongoing |
Z-0714-2025
|
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
|
Trokamed GmbH | Class I | Ongoing |
Z-0713-2025
|
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
|
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-…
|
SD Biosensor, Inc.
|
Class I | Ongoing |
Z-0668-2025
|
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstatio…
|
Draeger Medical, Inc.
|
Class I | Ongoing |
Z-0298-2025
|
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0300-2025
|
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0302-2025
|
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0301-2025
|
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0303-2025
|
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number …
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-0299-2025
|
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
|
Boston Scientific Corporation
|
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 …
|
Abbott Diabetes Care, Inc.
|
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…
|
Abbott Diabetes Care, Inc.
|
Class I | Ongoing |
Z-1322-2023
|
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U…
|
Philips Respironics, Inc.
|
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…
|
Datascope Corp.
|
Class I | Ongoing |
Z-0227-2025
|
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inne…
|
Elekta Instrument AB
|
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
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0208-2025
|
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provi…
|
Percussionaire Corporation
|
Class I | Ongoing |
Z-1138-2023
|
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
|
Draeger Medical, Inc.
|
Class I | Ongoing |
Z-1137-2023
|
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
|
Draeger Medical, Inc.
|
Class I | Ongoing |
Z-0047-2025
|
GE Heathcare Giraffe OmniBed; neo natal incubator
|
DATEX--OHMEDA, INC.
|
Class I | Ongoing |
Z-0004-2025
|
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
|
Mercury Enterprises, Inc. dba Mercury Medical
|
Class I | Ongoing |
Z-3085-2024
|
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-3083-2024
|
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-3084-2024
|
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0961-2023
|
Getinge Flow-e Anesthesia System, Part No. 6887900
|
Getinge Usa Sales Inc
|
Class I | Ongoing |
Z-0960-2023
|
Getinge Flow-c Anesthesia System, Part No. 6887700
|
Getinge Usa Sales Inc
|
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…
|
Getinge Usa Sales Inc
|
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, …
|
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,…
|
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, …
|
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…
|
Datascope Corp.
|
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…
|
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…
|
Datascope Corp.
|
Class I | Ongoing |
Z-3135-2024
|
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba…
|
Datascope Corp.
|
Class I | Ongoing |
Z-3137-2024
|
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba…
|
Datascope Corp.
|
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…
|
Fresenius Kabi USA, LLC
|
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…
|
Medtronic MiniMed, Inc.
|
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)…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-0962-2023
|
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
|
Smiths Medical ASD Inc.
|
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, …
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-0882-2023
|
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 10…
|
Philips Respironics, Inc.
|
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…
|
Covidien LP
|
Class I | Ongoing |
Z-2692-2024
|
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
|
Abbott Diabetes Care, Inc.
|
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…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2543-2024
|
RMU-2000 Automated Chest Compression Device
|
Defibtech, LLC
|
Class I | Ongoing |
Z-0237-2023
|
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
|
Whele LLC DBA Perch
|
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
|
Whele LLC DBA Perch
|
Class I | Ongoing |
Z-0236-2023
|
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
|
Whele LLC DBA Perch
|
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…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-3088-2024
|
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as foll…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-3087-2024
|
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as foll…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2974-2024
|
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-3090-2024
|
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2319-2024
|
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
|
Abiomed, Inc.
|
Class I | Ongoing |
Z-2599-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Produ…
|
Smiths Medical ASD Inc.
|
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…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2600-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH N…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2602-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List …
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2592-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/L…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2598-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2612-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2601-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Pro…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2591-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2608-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Pro…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2606-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2615-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/L…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2596-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/Li…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2590-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2605-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List N…
|
Smiths Medical ASD Inc.
|
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…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2594-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List …
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2603-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2613-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Produ…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2607-2024
|
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Cod…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-1783-2022
|
Wisp and Wisp Youth Nasal Mask
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1782-2022
|
DreamWisp Nasal Mask with Over the Nose Cushion
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1780-2022
|
Philips Respironics Amara View Minimal Contact Full-Face Mask
|
Philips Respironics, Inc.
|
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…
|
TELEFLEX LLC
|
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; …
|
TELEFLEX LLC
|
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…
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-0077-2023
|
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube a…
|
TELEFLEX LLC
|
Class I | Ongoing |
Z-1535-2024
|
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
|
SonarMed Inc
|
Class I | Ongoing |
Z-1666-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1642-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1680-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1639-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1649-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1521-2024
|
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
|
SonarMed Inc
|
Class I | Ongoing |
Z-1659-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1519-2024
|
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
|
SonarMed Inc
|
Class I | Ongoing |
Z-1655-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1673-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1675-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1640-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1679-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1643-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1667-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1670-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1685-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1644-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1652-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1681-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1682-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1520-2024
|
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
|
SonarMed Inc
|
Class I | Ongoing |
Z-1683-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1678-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1676-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1661-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1665-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1658-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1646-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1648-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1650-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1656-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1641-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1669-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1684-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1668-2024
|
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1464-2024
|
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; …
|
Biomerieux Inc
|
Class I | Ongoing |
Z-1560-2022
|
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number …
|
Getinge Usa Sales Inc
|
Class I | Ongoing |
Z-1612-2024
|
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices int…
|
ROUTE 92 MEDICAL INC
|
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…
|
ROUTE 92 MEDICAL INC
|
Class I | Ongoing |
Z-1611-2024
|
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventio…
|
ROUTE 92 MEDICAL INC
|
Class I | Ongoing |
Z-1610-2024
|
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional dev…
|
ROUTE 92 MEDICAL INC
|
Class I | Ongoing |
Z-1614-2024
|
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i…
|
ROUTE 92 MEDICAL INC
|
Class I | Ongoing |
Z-1484-2024
|
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
|
Fresenius Kabi USA, LLC
|
Class I | Ongoing |
Z-1485-2024
|
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
|
Outset Medical, Inc.
|
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…
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-1374-2024
|
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1512-2022
|
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
|
Heartware, Inc.
|
Class I | Ongoing |
Z-1525-2022
|
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
|
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
|
DeRoyal Industries Inc
|
Class I | Ongoing |
Z-1284-2024
|
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-cathe…
|
Medos International Sarl
|
Class I | Ongoing |
Z-1312-2022
|
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialy…
|
Covidien Llc
|
Class I | Ongoing |
Z-1315-2022
|
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, …
|
Covidien Llc
|
Class I | Ongoing |
Z-1317-2022
|
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion…
|
Covidien Llc
|
Class I | Ongoing |
Z-1318-2022
|
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusio…
|
Covidien Llc
|
Class I | Ongoing |
Z-1320-2022
|
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresi…
|
Covidien Llc
|
Class I | Ongoing |
Z-1211-2022
|
Drager SafeStar 55, Catalog No. MP01790
|
Draeger Medical, Inc.
|
Class I | Ongoing |
Z-0775-2024
|
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
|
Datex-Ohmeda, Inc.
|
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…
|
Wipro GE Healthcare Private Ltd.
|
Class I | Ongoing |
Z-1266-2022
|
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
|
Medtronic Inc
|
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
|
Wipro GE Healthcare Private Ltd.
|
Class I | Ongoing |
Z-0962-2024
|
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
|
Wipro GE Healthcare Private Ltd.
|
Class I | Ongoing |
Z-1081-2024
|
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
|
Windstone Medical Packaging, Inc.
|
Class I | Ongoing |
Z-1080-2024
|
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
|
Windstone Medical Packaging, Inc.
|
Class I | Ongoing |
Z-1082-2024
|
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
|
Windstone Medical Packaging, Inc.
|
Class I | Ongoing |
Z-1520-2022
|
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
|
Medtronic Xomed, Inc.
|
Class I | Ongoing |
Z-0863-2024
|
smiths medical Medfusion Model 3500 Syringe pump
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-0637-2024
|
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
|
Percussionaire Corporation
|
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…
|
Smiths Medical ASD Inc.
|
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…
|
Smiths Medical ASD Inc.
|
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…
|
GE Healthcare, LLC
|
Class I | Ongoing |
Z-1207-2022
|
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
|
Medtronic Inc
|
Class I | Ongoing |
Z-1049-2024
|
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-1044-2024
|
TRACH KIT W/HYDROGEN & SALI
|
Cardinal Health 200, LLC
|
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…
|
Cardinal Health 200, LLC
|
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
|
Cardinal Health 200, LLC
|
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…
|
Cardinal Health 200, LLC
|
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…
|
Cardinal Health 200, LLC
|
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…
|
Cardinal Health 200, LLC
|
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…
|
Cardinal Health 200, LLC
|
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…
|
Cardinal Health 200, LLC
|
Class I | Ongoing |
Z-0549-2024
|
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
|
Fresenius Kabi USA, LLC
|
Class I | Ongoing |
Z-0505-2024
|
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst…
|
Philips North America Llc
|
Class I | Ongoing |
Z-0966-2022
|
Puritan Bennett 980 Series Ventilator
|
Medtronic formerly Covidien | Class I | Ongoing |
Z-0918-2022
|
Cub 2 Enclosed Bed Canopy System
|
Sensory Medical Inc
|
Class I | Ongoing |
Z-0927-2022
|
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation Syst…
|
Medtronic Inc
|
Class I | Ongoing |
Z-0909-2022
|
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United State…
|
Respironics California, LLC
|
Class I | Ongoing |
Z-0908-2022
|
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
|
Respironics California, LLC
|
Class I | Ongoing |
Z-0907-2022
|
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709…
|
Respironics California, LLC
|
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)
|
Lusys Laboratories, Inc.
|
Class I | Ongoing |
Z-2631-2023
|
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) …
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-0529-2022
|
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-0004-2024
|
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet,…
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0002-2024
|
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intra…
|
ARROW INTERNATIONAL Inc.
|
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…
|
Datascope Corp.
|
Class I | Ongoing |
Z-2142-2023
|
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatr…
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-2140-2023
|
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory sup…
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-2141-2023
|
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and opt…
|
Hamilton Medical, Inc.
|
Class I | Ongoing |
Z-2028-2023
|
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
|
GE Healthcare Finland Oy
|
Class I | Ongoing |
Z-2027-2023
|
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
|
GE Healthcare Finland Oy
|
Class I | Ongoing |
Z-2034-2023
|
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
|
GE Healthcare Finland Oy
|
Class I | Ongoing |
Z-2032-2023
|
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia dete…
|
GE Healthcare Finland Oy
|
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…
|
MEDTECH SAS
|
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…
|
Datascope Corp.
|
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 …
|
DJO, LLC
|
Class I | Ongoing |
Z-2583-2021
|
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Ec…
|
North Coast Medical Inc
|
Class I | Ongoing |
Z-2582-2021
|
Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL…
|
North Coast Medical Inc
|
Class I | Ongoing |
Z-0068-2022
|
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
|
National Distribution & Contracting Inc
|
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…
|
National Distribution & Contracting Inc
|
Class I | Ongoing |
Z-0029-2022
|
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to…
|
Aesthetics Systems Usa Inc
|
Class I | Ongoing |
Z-0224-2022
|
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
|
Scrip Inc
|
Class I | Ongoing |
Z-2480-2021
|
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmiss…
|
AMTEC SALES Inc
|
Class I | Ongoing |
Z-0088-2022
|
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
|
Red Medical Supplies
|
Class I | Ongoing |
Z-0089-2022
|
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
|
Red Medical Supplies
|
Class I | Ongoing |
Z-0090-2022
|
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
|
Red Medical Supplies
|
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
|
Smiths Medical ASD Inc.
|
Class I | Ongoing |
Z-2286-2021
|
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indic…
|
Cardinal Health
|
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…
|
Cardinal Health
|
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…
|
Cardinal Health
|
Class I | Ongoing |
Z-1489-2023
|
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
|
Cordis US Corp
|
Class I | Ongoing |
Z-1490-2023
|
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
|
Cordis US Corp
|
Class I | Ongoing |
Z-1487-2023
|
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
|
Cordis US Corp
|
Class I | Ongoing |
Z-1494-2023
|
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
|
Cordis US Corp
|
Class I | Ongoing |
Z-1495-2023
|
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
|
Cordis US Corp
|
Class I | Ongoing |
Z-1484-2023
|
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
|
Cordis US Corp
|
Class I | Ongoing |
Z-1565-2023
|
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
|
ICU Medical Inc
|
Class I | Ongoing |
Z-1567-2023
|
ASM Replacement Battery, Component Number SUB0000864
|
ICU Medical Inc
|
Class I | Ongoing |
Z-1568-2023
|
ASM Replacement Battery, Component Number SUB0000594
|
ICU Medical Inc
|
Class I | Ongoing |
Z-1313-2023
|
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
|
Fresenius Kabi USA, LLC
|
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…
|
Respironics California, LLC
|
Class I | Ongoing |
Z-1956-2021
|
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1958-2021
|
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1359-2020
|
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
|
CareFusion 303, Inc.
|
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…
|
LeMaitre Vascular, Inc.
|
Class I | Ongoing |
Z-2451-2019
|
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: …
|
Allergan PLC
|
Class I | Ongoing |
Z-2190-2021
|
HeartWare HVAD Pump Implant Kit, REF 1125
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2456-2019
|
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact…
|
Allergan PLC
|
Class I | Ongoing |
Z-1555-2020
|
Imager II 5F Angiographic Catheters, 5 units per package.
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2463-2019
|
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Br…
|
Allergan PLC
|
Class I | Ongoing |
Z-1362-2020
|
CareFusion Alaris PCA Module, Model 8120
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-1531-2021
|
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers …
|
St. Jude Medical, Cardian Rhythm Management Division
|
Class I | Ongoing |
Z-1832-2017
|
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the drive…
|
Heartware
|
Class I | Ongoing |
Z-0099-2019
|
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
|
Maquet Datascope Corp - Cardiac Assist Division
|
Class I | Ongoing |
Z-2191-2021
|
HeartWare HVAD Pump Implant Kit, REF 1153
|
Heartware, Inc.
|
Class I | Ongoing |
Z-1306-2021
|
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT C…
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-2196-2021
|
HeartWare HVAD Outflow Graft, REF MCS1725OG
|
Heartware, Inc.
|
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…
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-0100-2019
|
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
|
Maquet Datascope Corp - Cardiac Assist Division
|
Class I | Ongoing |
Z-1539-2021
|
COVID-19 Self-Test Kit *** INNOVA *** 3T
|
INNOVA MEDICAL GROUP, INC.
|
Class I | Ongoing |
Z-2197-2021
|
HeartWare HVAD Pump Accessories, REF MCS1753AK
|
Heartware, Inc.
|
Class I | Ongoing |
Z-1201-2021
|
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
|
Medtronic Vascular, Inc.
|
Class I | Ongoing |
Z-2465-2019
|
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH an…
|
Allergan PLC
|
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 …
|
Heartware, Inc.
|
Class I | Ongoing |
Z-1942-2019
|
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
|
Datascope Corp.
|
Class I | Ongoing |
Z-1941-2019
|
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
|
Datascope Corp.
|
Class I | Ongoing |
Z-1360-2020
|
CareFusion Alaris Pump Module, Model 8100
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-1944-2019
|
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
|
Datascope Corp.
|
Class I | Ongoing |
Z-1313-2021
|
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1…
|
Medtronic Perfusion Systems
|
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 …
|
Allergan PLC
|
Class I | Ongoing |
Z-1361-2020
|
CareFusion Alaris Syringe Module, Model 8110
|
CareFusion 303, Inc.
|
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. …
|
HeartWare Inc
|
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…
|
INNOVA MEDICAL GROUP, INC.
|
Class I | Ongoing |
Z-2453-2019
|
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-12…
|
Allergan PLC
|
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…
|
Allergan PLC
|
Class I | Ongoing |
Z-2458-2019
|
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation …
|
Allergan PLC
|
Class I | Ongoing |
Z-1939-2019
|
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
|
Datascope Corp.
|
Class I | Ongoing |
Z-1903-2018
|
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Pro…
|
Heartware
|
Class I | Ongoing |
Z-1943-2019
|
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
|
Datascope Corp.
|
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…
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-2192-2021
|
HeartWare HVAD Driveline Extension Cable, REF 100
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2454-2019
|
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numb…
|
Allergan PLC
|
Class I | Ongoing |
Z-2188-2021
|
HeartWare HVAD Pump Implant Kit, REF 1103
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2189-2021
|
HeartWare HVAD Pump Implant Kit, REF 1104
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2194-2021
|
HeartWare HVAD Implant Kit, REF 1104JP
|
Heartware, Inc.
|
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…
|
Maquet Datascope Corp - Cardiac Assist Division
|
Class I | Ongoing |
Z-2457-2019
|
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle …
|
Allergan PLC
|
Class I | Ongoing |
Z-1966-2026
|
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
|
Philips North America
|
Class II | Ongoing |
Z-1968-2026
|
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe…
|
Philips North America
|
Class II | Ongoing |
Z-1958-2026
|
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. …
|
Philips North America
|
Class II | Ongoing |
Z-1955-2026
|
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):…
|
Philips North America
|
Class II | Ongoing |
Z-1960-2026
|
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782…
|
Philips North America
|
Class II | Ongoing |
Z-1951-2026
|
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
|
Philips North America
|
Class II | Ongoing |
Z-1957-2026
|
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
|
Philips North America
|
Class II | Ongoing |
Z-1963-2026
|
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821…
|
Philips North America
|
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…
|
Philips North America
|
Class II | Ongoing |
Z-1952-2026
|
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
|
Philips North America
|
Class II | Ongoing |
Z-1956-2026
|
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. …
|
Philips North America
|
Class II | Ongoing |
Z-1964-2026
|
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
|
Philips North America
|
Class II | Ongoing |
Z-1982-2026
|
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-1988-2026
|
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
|
DEPUY (IRELAND) | Class II | Ongoing |
Z-1986-2026
|
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
|
DEPUY (IRELAND) | Class II | Ongoing |
Z-1991-2026
|
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
|
DEPUY (IRELAND) | Class II | Ongoing |
Z-1993-2026
|
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
|
DEPUY (IRELAND) | Class II | Ongoing |
Z-1987-2026
|
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
|
DEPUY (IRELAND) | Class II | Ongoing |
Z-2003-2026
|
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-2001-2026
|
i-STAT G3+ cartridge; List Number: 03P78-26;
|
Abbott Point Of Care Inc.
|
Class II | Ongoing |
Z-1999-2026
|
i-STAT EG7+ cartridge; List Number: 03P76-25;
|
Abbott Point Of Care Inc.
|
Class II | Ongoing |
Z-1918-2026
|
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
|
Micro-X Ltd.
|
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 …
|
Immuno-Mycologics, Inc
|
Class II | Ongoing |
Z-1903-2026
|
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1901-2026
|
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1907-2026
|
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1902-2026
|
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1908-2026
|
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1906-2026
|
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1896-2026
|
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
|
Davol, Inc.
|
Class II | Ongoing |
Z-1900-2026
|
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1806-2026
|
Yeastone Broth, 11ML, 10/BOX YY3462
|
Remel, Inc
|
Class II | Ongoing |
Z-1949-2026
|
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: …
|
Hologic, Inc
|
Class II | Ongoing |
Z-1823-2026
|
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
|
Gentuity, LLC
|
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…
|
Advanced Bionics, LLC
|
Class II | Ongoing |
Z-1820-2026
|
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-1805-2026
|
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-1816-2026
|
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-1980-2026
|
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-1632-2026
|
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
|
Straumann USA LLC
|
Class II | Ongoing |
Z-2040-2026
|
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2045-2026
|
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVEL…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2041-2026
|
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1924-2026
|
Flamingo Funnel Small, Model Number SQ20012-01
|
SurgiSmoke Solutions
|
Class II | Ongoing |
Z-1922-2026
|
Access Total T4 Calibrator, Catalog No. 33805
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-2043-2026
|
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2042-2026
|
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE T…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1925-2026
|
Flamingo Funnel Medium, Model Number SQ20012-02
|
SurgiSmoke Solutions
|
Class II | Ongoing |
Z-1824-2026
|
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
|
Medline Industries, LP
|
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…
|
Magellan Diagnostics, Inc.
|
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 …
|
Magellan Diagnostics, Inc.
|
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…
|
Magellan Diagnostics, Inc.
|
Class II | Ongoing |
Z-1996-2026
|
iLet Bionic Pancreas, REF: BB1001
|
Beta Bionics, Inc.
|
Class II | Ongoing |
Z-1943-2026
|
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
|
Healthmark Industries Co., Inc.
|
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…
|
ARROW INTERNATIONAL, LLC
|
Class II | Ongoing |
Z-1920-2026
|
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
|
Windstone Medical Packaging, Inc.
|
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…
|
ARROW INTERNATIONAL, LLC
|
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:…
|
ARROW INTERNATIONAL, LLC
|
Class II | Ongoing |
Z-1913-2026
|
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: …
|
ARROW INTERNATIONAL, LLC
|
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…
|
ARROW INTERNATIONAL, LLC
|
Class II | Ongoing |
Z-1921-2026
|
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
|
Windstone Medical Packaging, Inc.
|
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…
|
ARROW INTERNATIONAL, LLC
|
Class II | Ongoing |
Z-1811-2026
|
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
|
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
|
Class II | Ongoing |
Z-1653-2026
|
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
|
Siemens Medical Solutions USA, Inc
|
Class II | Ongoing |
Z-1933-2026
|
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
|
LSL Healthcare Inc.
|
Class II | Ongoing |
Z-1930-2026
|
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
|
LSL Healthcare Inc.
|
Class II | Ongoing |
Z-1944-2026
|
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
|
Milestone S.R.L. | Class II | Ongoing |
Z-1929-2026
|
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
|
LSL Healthcare Inc.
|
Class II | Ongoing |
Z-1928-2026
|
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
|
LSL Healthcare Inc.
|
Class II | Ongoing |
Z-1932-2026
|
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
|
LSL Healthcare Inc.
|
Class II | Ongoing |
Z-1825-2026
|
Philips Spectral CT on Rails. Model Number: 728334.
|
PHILIPS MEDICAL SYSTEMS
|
Class II | Ongoing |
Z-0831-2025
|
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with th…
|
Nuwellis Inc
|
Class I | Completed |
Z-1828-2026
|
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
|
Integra LifeSciences Corp. (NeuroSciences)
|
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 …
|
Tornier, Inc
|
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…
|
Angiodynamics, Inc.
|
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…
|
Angiodynamics, Inc.
|
Class II | Ongoing |
Z-1664-2026
|
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
|
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…
|
Angiodynamics, Inc.
|
Class II | Ongoing |
Z-1672-2026
|
Allura Xper FD20/15 OR Table; System Code: 722059;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1673-2026
|
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
|
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/…
|
Angiodynamics, Inc.
|
Class II | Ongoing |
Z-1812-2026
|
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
|
Wilson-Cook Medical Inc.
|
Class II | Ongoing |
Z-1676-2026
|
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
|
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; …
|
Angiodynamics, Inc.
|
Class II | Ongoing |
Z-1679-2026
|
Azurion 5 M12; System Code: (1)722227, (2)722231;
|
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…
|
Angiodynamics, Inc.
|
Class II | Ongoing |
Z-1766-2026
|
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
|
Oxoid Australia Pty Limited | Class II | Ongoing |
Z-1666-2026
|
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1660-2026
|
ALLURA Xper FD10F; System Code: 722002;
|
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…
|
Angiodynamics, Inc.
|
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…
|
Angiodynamics, Inc.
|
Class II | Ongoing |
Z-1668-2026
|
Allura Xper FD20/10; System Code: 722029;
|
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…
|
Angiodynamics, Inc.
|
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…
|
Angiodynamics, Inc.
|
Class II | Ongoing |
Z-1665-2026
|
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
|
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);
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1677-2026
|
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
|
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; …
|
Angiodynamics, Inc.
|
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…
|
Angiodynamics, Inc.
|
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…
|
Angiodynamics, Inc.
|
Class II | Ongoing |
Z-1767-2026
|
SIGNA Premier systems
|
GE Healthcare LLC
|
Class II | Ongoing |
Z-1885-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ90939…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1878-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMI…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1884-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1883-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits conta…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1876-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 AN…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1886-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1892-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1694-2026
|
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1888-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1887-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1877-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1882-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ8034…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1889-2026
|
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1838-2026
|
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
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,…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1834-2026
|
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGR…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1702-2026
|
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
|
Synthes (USA) Products LLC
|
Class II | Ongoing |
Z-1642-2026
|
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Prod…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1847-2026
|
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
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…
|
Olympus Corporation of the Americas
|
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, …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1830-2026
|
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
|
Medline Industries, LP
|
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…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1841-2026
|
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1845-2026
|
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1840-2026
|
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
|
Medline Industries, LP
|
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…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1850-2026
|
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1849-2026
|
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1842-2026
|
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLAND…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1831-2026
|
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, M…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1657-2026
|
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-1821-2026
|
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL …
|
Clariance-SAS
|
Class II | Ongoing |
Z-1634-2026
|
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Sim…
|
AMO Puerto Rico Manufacturing, Inc.
|
Class II | Ongoing |
Z-1685-2026
|
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150…
|
Mentor Texas, LP.
|
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…
|
Mentor Texas, LP.
|
Class II | Ongoing |
Z-1581-2026
|
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksel…
|
Elekta, Inc.
|
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…
|
Mentor Texas, LP.
|
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…
|
Mentor Texas, LP.
|
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…
|
Mentor Texas, LP.
|
Class II | Ongoing |
Z-1580-2026
|
Cub Pediatric Crib, Model FL19H
|
Stryker Medical Division of Stryker Corporation
|
Class II | Ongoing |
Z-1586-2026
|
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima …
|
Hologic, Inc.
|
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…
|
Mentor Texas, LP.
|
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 …
|
Mentor Texas, LP.
|
Class II | Ongoing |
Z-1774-2026
|
See Luer Cap Set, MPC-130, set, administration, intravascular
|
Molded Products Inc
|
Class II | Ongoing |
Z-1707-2026
|
THORACIC ROBOTS, DYNJ908777B
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1705-2026
|
Airway Exam Kit, DYKE1796
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1709-2026
|
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY K…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1710-2026
|
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ9…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1582-2026
|
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
|
ConvaTec, Inc
|
Class II | Ongoing |
Z-1583-2026
|
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
|
ConvaTec, Inc
|
Class II | Ongoing |
Z-1745-2026
|
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1749-2026
|
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1752-2026
|
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1747-2026
|
MiniMed 620G Insulin Pump (MMT-1750)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1748-2026
|
Paradigm Insulin Pump (MMT-712, MMT-715)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1746-2026
|
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1750-2026
|
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
|
Medtronic MiniMed, Inc.
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1690-2026
|
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1751-2026
|
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1741-2026
|
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1743-2026
|
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1740-2026
|
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1610-2026
|
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1613-2026
|
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1612-2026
|
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1611-2026
|
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1757-2026
|
Burlington Medical, Wrap Aprons.
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1761-2026
|
Burlington Medical, Leg Wraps.
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1762-2026
|
Burlington Medical, Half Aprons.
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1754-2026
|
Burlington Medical, Vest
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1763-2026
|
Burlington Medical, Demi Half Aprons.
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1645-2026
|
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-1765-2026
|
Burlington Medical, Kilt Blockers.
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1759-2026
|
Burlington Medical, Protective Sleeves.
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1756-2026
|
Burlington Medical, Frontal Aprons
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1764-2026
|
Burlington Medical, Blockers.
|
Burlington Medical, LLC
|
Class II | Ongoing |
Z-1629-2026
|
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
|
Orthalign, Inc
|
Class II | Ongoing |
Z-1630-2026
|
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
|
Orthalign, Inc
|
Class II | Ongoing |
Z-1574-2026
|
Artegraft Vascular Graft; REF#: AG740;
|
LeMaitre Vascular, Inc.
|
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…
|
Abbott Diagnostics Scarborough, Inc.
|
Class II | Ongoing |
Z-1554-2026
|
Artelon FlexBand Dynamic Matrix Ref: 31057
|
International Life Sciences
|
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…
|
International Life Sciences
|
Class II | Ongoing |
Z-1555-2026
|
Artelon FlexBand Plus Ref: 41054 & 41057
|
International Life Sciences
|
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 …
|
Diagnostica Stago, Inc.
|
Class II | Ongoing |
Z-1815-2026
|
React Health PHOENIX 5L Oxygen Concentrator
|
3B Medical, Inc.
|
Class II | Ongoing |
Z-1590-2026
|
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8…
|
GE Medical Systems, LLC
|
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…
|
B Braun Medical Inc
|
Class II | Ongoing |
Z-1572-2026
|
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
|
Howmedica Osteonics Corp.
|
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…
|
B Braun Medical Inc
|
Class II | Ongoing |
Z-1553-2026
|
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
|
Beckman Coulter Mishima K.K.
|
Class II | Ongoing |
Z-1562-2026
|
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2)…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1552-2026
|
DxC 700 AU, REF: B86444, B86446
|
Beckman Coulter Mishima K.K.
|
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…
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-1635-2026
|
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
|
Medtronic MiniMed, Inc.
|
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…
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-1557-2026
|
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03…
|
Covidien LLC
|
Class II | Ongoing |
Z-0432-2023
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0455-2023
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0431-2023
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
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…
|
Olympus Corporation of the Americas
|
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 …
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0438-2023
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0442-2023
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0428-2023
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0433-2023
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0454-2023
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0453-2023
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0426-2023
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0446-2023
|
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0450-2023
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-1655-2026
|
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS…
|
ReCor Medical Inc.
|
Class II | Ongoing |
Z-0436-2023
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0443-2023
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0439-2023
|
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0448-2023
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0437-2023
|
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0447-2023
|
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
Class I | Ongoing |
Z-0445-2023
|
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
|
ARROW INTERNATIONAL Inc.
|
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.
|
Becton Dickinson & Company
|
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.…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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 -…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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, …
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-1606-2026
|
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31…
|
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 …
|
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…
|
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; …
|
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…
|
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…
|
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…
|
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…
|
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…
|
I.T.S. GmbH | Class II | Ongoing |
Z-1487-2026
|
CS300 IABP. Software Version CS300 IABP C.01.
|
Datascope Corp.
|
Class II | Ongoing |
Z-1486-2026
|
CS100 IABP. Software Version CS100 IABP Q.01.
|
Datascope Corp.
|
Class II | Ongoing |
Z-1601-2026
|
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1.…
|
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…
|
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…
|
Auris Health, Inc
|
Class II | Ongoing |
Z-1544-2026
|
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 0072190…
|
Physio-Control, Inc.
|
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…
|
Stryker Corporation
|
Class II | Ongoing |
Z-1524-2026
|
GEM Premier 5000 PAK, Part No. 00055360004.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1533-2026
|
GEM Premier 5000; Part No. 00055415005.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1539-2026
|
GEM Premier 5000; Model No. 00055430010.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1538-2026
|
GEM Premier 5000; Part No. 00055430008.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1534-2026
|
GEM Premier 5000; Part No. 00055415008.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1531-2026
|
GEM Premier 5000 PAK; Part No. 00055407511.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1527-2026
|
GEM Premier 5000 PAK; Part No. 00055360011.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1529-2026
|
GEM Premier 5000 PAK; Part No. 00055407508.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1542-2026
|
GEM Premier 5000; Part No. 00055445008.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1530-2026
|
GEM Premier 5000 PAK; Part No. 00055407510.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1525-2026
|
GEM Premier 5000 PAK; Part No. 00055360008.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1541-2026
|
GEM Premier 5000; Part No. 00055445004.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1476-2026
|
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464…
|
Roche Diagnostics Operations, Inc.
|
Class II | Ongoing |
Z-1484-2026
|
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-1535-2026
|
GEM Premier 5000; Part No. 00055415010.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1537-2026
|
GEM Premier 5000; Part No. 00055430004.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1536-2026
|
GEM Premier 5000; Part No: 00055415011.
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1363-2026
|
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing wit…
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-1365-2026
|
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conduc…
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-1475-2026
|
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; …
|
GE Healthcare
|
Class II | Ongoing |
Z-1364-2026
|
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONE…
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-1458-2026
|
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Mo…
|
Encore Medical, LP
|
Class II | Ongoing |
Z-1460-2026
|
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/C…
|
Encore Medical, LP
|
Class II | Ongoing |
Z-1485-2026
|
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Vers…
|
Aesculap Inc
|
Class II | Ongoing |
Z-1462-2026
|
PIE PAK Models: P2HC-A, P2HC-S, P2HC
|
Edermy LLC
|
Class II | Ongoing |
Z-1473-2026
|
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
|
Medtronic Perfusion Systems
|
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…
|
Laerdal Medical Corporation
|
Class II | Ongoing |
Z-1521-2026
|
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-1517-2026
|
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-0143-2023
|
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P0…
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-1511-2026
|
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-1520-2026
|
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-0142-2023
|
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P0…
|
Baxter Healthcare Corporation
|
Class I | Ongoing |
Z-1512-2026
|
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
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…
|
Medartis AG
|
Class II | Ongoing |
Z-1299-2026
|
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
|
FUJIFILM Healthcare Americas Corporation
|
Class II | Ongoing |
Z-1464-2026
|
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1468-2026
|
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1465-2026
|
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LI…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1463-2026
|
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU C…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1467-2026
|
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESS…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1290-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instr…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1287-2026
|
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These ins…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1392-2026
|
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1407-2026
|
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
|
Medline Industries, LP
|
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…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1315-2026
|
Brilliance iCT; Product Code (REF): 728306;
|
Philips North America Llc
|
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…
|
Olympus Corporation of the Americas
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1406-2026
|
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1317-2026
|
Spectral CT; Product Code (REF): 728333;
|
Philips North America Llc
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1410-2026
|
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1289-2026
|
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1296-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instr…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1419-2026
|
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Mode…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1270-2026
|
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These ins…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1288-2026
|
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These ins…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1297-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software …
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1286-2026
|
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1278-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software …
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1395-2026
|
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C…
|
Medline Industries, LP
|
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…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1405-2026
|
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1385-2026
|
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: D…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1394-2026
|
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1398-2026
|
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1277-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1408-2026
|
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1285-2026
|
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These ins…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1411-2026
|
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1268-2026
|
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software…
|
Olympus Corporation of the Americas
|
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…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1384-2026
|
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Num…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1403-2026
|
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1415-2026
|
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS98…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1316-2026
|
IQon Spectral CT; Product Code (REF): 728332;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1404-2026
|
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BUR…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
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…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1397-2026
|
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Nu…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1280-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software …
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1413-2026
|
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1279-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software …
|
Olympus Corporation of the Americas
|
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…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1292-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instr…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1414-2026
|
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1400-2026
|
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Mode…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1425-2026
|
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1295-2026
|
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instr…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1227-2026
|
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
VANTIVE US HEALTHCARE LLC
|
Class II | Ongoing |
Z-1224-2026
|
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
VANTIVE US HEALTHCARE LLC
|
Class II | Ongoing |
Z-1226-2026
|
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
VANTIVE US HEALTHCARE LLC
|
Class II | Ongoing |
Z-1228-2026
|
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
VANTIVE US HEALTHCARE LLC
|
Class II | Ongoing |
Z-1231-2026
|
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
VANTIVE US HEALTHCARE LLC
|
Class II | Ongoing |
Z-1229-2026
|
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
VANTIVE US HEALTHCARE LLC
|
Class II | Ongoing |
Z-1225-2026
|
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
VANTIVE US HEALTHCARE LLC
|
Class II | Ongoing |
Z-1236-2026
|
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem…
|
Biomerieux Inc
|
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…
|
Raz Design Inc
|
Class II | Ongoing |
Z-1434-2026
|
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
|
Medline Industries, LP
|
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,…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1338-2026
|
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
|
AVID Medical, Inc.
|
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;…
|
Alphatec Spine, Inc.
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1220-2026
|
BEAR Implant. Model Number: 1000.
|
Miach Orthopaedics
|
Class II | Ongoing |
Z-1355-2026
|
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
|
Intuitive Surgical, Inc.
|
Class II | Ongoing |
Z-1174-2026
|
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Ve…
|
Siemens Medical Solutions USA, Inc
|
Class II | Ongoing |
Z-1165-2026
|
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
|
Cerapedics, Inc.
|
Class II | Ongoing |
Z-1203-2026
|
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2.…
|
Cardinal Health 200, LLC
|
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…
|
GOLD STAR DISTRIBUTION INC
|
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…
|
GOLD STAR DISTRIBUTION INC
|
Class II | Ongoing |
Z-1331-2026
|
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1312-2026
|
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1328-2026
|
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
|
Medline Industries, LP
|
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…
|
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | Class II | Ongoing |
Z-1243-2026
|
Focalyx Fusion
|
Focalyx Technologies, LLC.
|
Class II | Ongoing |
Z-1219-2026
|
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
|
LSL Healthcare Inc.
|
Class II | Ongoing |
Z-1017-2026
|
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
|
Canon Medical System, USA, INC.
|
Class II | Ongoing |
Z-1111-2026
|
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
|
ICU Medical, Inc.
|
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…
|
Tyber Medical
|
Class II | Ongoing |
Z-1177-2026
|
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
|
Canon Medical System, USA, INC.
|
Class II | Ongoing |
Z-1242-2026
|
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPE…
|
Siemens Medical Solutions USA, Inc
|
Class II | Ongoing |
Z-1239-2026
|
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
|
Siemens Medical Solutions USA, Inc
|
Class II | Ongoing |
Z-1100-2026
|
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
|
ICU Medical Inc.
|
Class II | Ongoing |
Z-1018-2026
|
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
|
Canon Medical System, USA, INC.
|
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.
|
Altruan GmbH
|
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…
|
Community Products, LLC
|
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…
|
Community Products, LLC
|
Class II | Ongoing |
Z-1173-2026
|
AlternatiV+ Screw-In Anchor
|
Aju Pharm Co., Ltd.
|
Class II | Ongoing |
Z-1171-2026
|
Genesis Push-In Suture Anchor
|
Aju Pharm Co., Ltd.
|
Class II | Ongoing |
Z-1167-2026
|
Fixone Biocomposite Anchor
|
Aju Pharm Co., Ltd.
|
Class II | Ongoing |
Z-1166-2026
|
Fixone Hybrid Anchor
|
Aju Pharm Co., Ltd.
|
Class II | Ongoing |
Z-1170-2026
|
Genesis Knotless Anchor
|
Aju Pharm Co., Ltd.
|
Class II | Ongoing |
Z-1172-2026
|
AlternatiV+ Max Knotless Anchor
|
Aju Pharm Co., Ltd.
|
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…
|
Vortex Surgical Inc.
|
Class II | Ongoing |
Z-1090-2026
|
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1089-2026
|
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY C…
|
Medline Industries, LP
|
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. …
|
Vortex Surgical Inc.
|
Class II | Ongoing |
Z-1254-2026
|
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
|
Vortex Surgical Inc.
|
Class II | Ongoing |
Z-1252-2026
|
Vortex Surgical I2 Injection Kit, VS0500
|
Vortex Surgical Inc.
|
Class II | Ongoing |
Z-1255-2026
|
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
|
Vortex Surgical Inc.
|
Class II | Ongoing |
Z-1086-2026
|
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOP…
|
Medline Industries, LP
|
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…
|
Vortex Surgical Inc.
|
Class II | Ongoing |
Z-1369-2026
|
Estrone RIA, REF: DSL8700
|
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…
|
Intuitive Surgical, Inc.
|
Class II | Ongoing |
Z-1063-2026
|
Allura Xper FD10F; Model Number: 722002;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1074-2026
|
Allura Xper FD10/10; Model Number: 722027;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1075-2026
|
Allura Xper FD20; Model Number: 722028;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1062-2026
|
Product Name: Allura Xper FD10C; Model number: 722001;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1064-2026
|
Allura Xper FD10; Model Number: 722003;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1118-2026
|
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-1120-2026
|
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-1069-2026
|
Allura Xper FD10/10; Model Number: 722011;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1077-2026
|
Allura Xper FD20/20; Model Number: 722038;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1065-2026
|
Allura Xper FD10/10; Model Number: 722005;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1070-2026
|
Allura Xper FD20; Model Number: 722012;
|
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…
|
Diagnostica Stago, Inc.
|
Class II | Ongoing |
Z-1076-2026
|
Allura Xper FD20/10; Model Number: 722029;
|
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)
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-1036-2026
|
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when di…
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-1200-2026
|
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1340-2026
|
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr…
|
Elekta, Inc.
|
Class II | Ongoing |
Z-1186-2026
|
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1367-2026
|
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
|
Bard Peripheral Vascular Inc
|
Class II | Ongoing |
Z-1189-2026
|
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST …
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
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 …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1194-2026
|
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1093-2026
|
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
|
Hologic, Inc
|
Class II | Ongoing |
Z-1196-2026
|
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1197-2026
|
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELV…
|
Medline Industries, LP
|
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…
|
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…
|
Fujirebio Diagnostics, Inc.
|
Class II | Ongoing |
Z-1303-2026
|
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Pr…
|
Fujirebio Diagnostics, Inc.
|
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…
|
Fujirebio Diagnostics, Inc.
|
Class II | Ongoing |
Z-1307-2026
|
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Produc…
|
Fujirebio Diagnostics, Inc.
|
Class II | Ongoing |
Z-1078-2026
|
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
|
Elekta, Inc.
|
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…
|
Intuitive Surgical, Inc.
|
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…
|
Intuitive Surgical, Inc.
|
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…
|
Intuitive Surgical, Inc.
|
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…
|
Intuitive Surgical, Inc.
|
Class II | Ongoing |
Z-1654-2022
|
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1079-2026
|
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M…
|
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…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1658-2022
|
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstru…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1659-2022
|
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patient…
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1034-2026
|
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000,…
|
IMRIS Imaging Inc
|
Class II | Ongoing |
Z-1008-2026
|
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
|
Beaver-Visitec International, Inc.
|
Class II | Ongoing |
Z-1019-2026
|
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
|
Meridian Bioscience Inc
|
Class II | Ongoing |
Z-1124-2026
|
Allwell Inflation Device, for angiographic use REF: IS-30-A
|
Merit Medical Systems, Inc.
|
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…
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-1127-2026
|
Merit Medical , Custom Manifold Kit REF: K09-13203A
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-1040-2026
|
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
|
Mobius Imaging, LLC
|
Class II | Ongoing |
Z-1125-2026
|
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
|
Merit Medical Systems, Inc.
|
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…
|
Merit Medical Systems, Inc.
|
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.
|
Philips North America
|
Class II | Ongoing |
Z-1209-2026
|
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
|
Philips North America
|
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, …
|
CareFusion 303, Inc.
|
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 …
|
Medtronic Neuromodulation
|
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.
|
Philips North America
|
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.
|
Philips North America
|
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.
|
Philips North America
|
Class II | Ongoing |
Z-1208-2026
|
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
|
Philips North America
|
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.…
|
Philips North America
|
Class II | Ongoing |
Z-1205-2026
|
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
|
Philips North America
|
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.
|
Philips North America
|
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.…
|
Philips North America
|
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…
|
Philips North America
|
Class II | Ongoing |
Z-1214-2026
|
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
|
Philips North America
|
Class II | Ongoing |
Z-0972-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0970-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0975-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0984-2026
|
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
|
Microbiologics Inc
|
Class II | Ongoing |
Z-0968-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0982-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0974-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0971-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0969-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0980-2026
|
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-0985-2026
|
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
|
Microbiologics Inc
|
Class II | Ongoing |
Z-0986-2026
|
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
|
Microbiologics Inc
|
Class II | Ongoing |
Z-1061-2026
|
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
|
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | Class II | Ongoing |
Z-1121-2026
|
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1054-2026
|
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL P…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1025-2026
|
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-1026-2026
|
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
|
Beckman Coulter, Inc.
|
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…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1049-2026
|
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH K…
|
Medline Industries, LP
|
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 …
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1005-2026
|
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description:…
|
Ferndale Laboratories, Inc.
|
Class II | Ongoing |
Z-0957-2026
|
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
|
Smith & Nephew, Inc.
|
Class II | Ongoing |
Z-0965-2026
|
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0966-2026
|
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-1262-2026
|
Male Fertility Sperm Test for Home Use (Cassette)
|
Changchun Wancheng Bio-Electron Co., Ltd.
|
Class II | Ongoing |
Z-1263-2026
|
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
|
Changchun Wancheng Bio-Electron Co., Ltd.
|
Class II | Ongoing |
Z-1265-2026
|
Vivoo Protein Test
|
Changchun Wancheng Bio-Electron Co., Ltd.
|
Class II | Ongoing |
Z-1257-2026
|
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in…
|
Changchun Wancheng Bio-Electron Co., Ltd.
|
Class II | Ongoing |
Z-1261-2026
|
S. Typhi/Para Typhi A Antigen
|
Changchun Wancheng Bio-Electron Co., Ltd.
|
Class II | Ongoing |
Z-0323-2023
|
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
|
DEWEI MEDICAL EQUIPMENT CO LTD
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-1048-2026
|
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
|
Fresenius Kabi USA, LLC
|
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…
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-0996-2026
|
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90…
|
Medtronic Neuromodulation
|
Class II | Ongoing |
Z-0909-2026
|
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfect…
|
Steris Corporation
|
Class II | Ongoing |
Z-0910-2026
|
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfec…
|
Steris Corporation
|
Class II | Ongoing |
Z-0920-2026
|
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring …
|
Mindray DS USA, Inc. dba Mindray North America
|
Class II | Ongoing |
Z-0923-2026
|
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
|
AGFA Healthcare Corp.
|
Class II | Ongoing |
Z-1311-2026
|
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,…
|
ETAC A/S
|
Class II | Ongoing |
Z-1029-2026
|
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
|
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, …
|
ETAC A/S
|
Class II | Ongoing |
Z-1479-2026
|
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog …
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0961-2026
|
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
|
Abbott Laboratories
|
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…
|
Howmedica Osteonics Corp.
|
Class II | Ongoing |
Z-0897-2026
|
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-1454-2026
|
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1442-2026
|
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applicatio…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1450-2026
|
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1445-2026
|
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1455-2026
|
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1446-2026
|
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatio…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1447-2026
|
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1439-2026
|
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1444-2026
|
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic application…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1448-2026
|
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1452-2026
|
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1449-2026
|
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1440-2026
|
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1457-2026
|
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1453-2026
|
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
|
Olympus Corporation of the Americas
|
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…
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-0889-2026
|
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio…
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-0907-2026
|
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
|
C.R. Bard Inc
|
Class II | Ongoing |
Z-0905-2026
|
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
|
C.R. Bard Inc
|
Class II | Ongoing |
Z-0906-2026
|
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
|
C.R. Bard Inc
|
Class II | Ongoing |
Z-0724-2026
|
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
|
Cepheid
|
Class II | Ongoing |
Z-0992-2026
|
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C…
|
Diasol, Inc
|
Class II | Ongoing |
Z-0987-2026
|
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C…
|
Diasol, Inc
|
Class II | Ongoing |
Z-0989-2026
|
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C…
|
Diasol, Inc
|
Class II | Ongoing |
Z-0917-2026
|
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
|
Datascope Corp.
|
Class II | Ongoing |
Z-0916-2026
|
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
|
Datascope Corp.
|
Class II | Ongoing |
Z-0808-2026
|
Food Intolerance Test Small
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0756-2026
|
Vitamin D-Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0775-2026
|
Candida Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0767-2026
|
Organic Acids Profile Test Large
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0769-2026
|
Allergy Test IgE
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0804-2026
|
Allergy test Small
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0764-2026
|
GI Microbiome Profile XL
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0733-2026
|
Illegally Marketed
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0741-2026
|
HPV Antigen Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0750-2026
|
Sperm Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0746-2026
|
Mycoplasma test, IgG and IgM
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0793-2026
|
Parasite Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0772-2026
|
Adrenal Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0790-2026
|
Neurotransmitters Plus
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0814-2026
|
Pollen Allergy Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0848-2026
|
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
|
Fresenius Kabi USA, LLC
|
Class II | Ongoing |
Z-0727-2026
|
Alcohol (ALC) Test Saliva
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0782-2026
|
Gut Microbiome Test XL
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0813-2026
|
Pet Allergy Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0754-2026
|
Urinary Tract Infection Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0786-2026
|
Lactose Intolerance Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0795-2026
|
PSA Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0781-2026
|
Gut Microbiome Test Small
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0818-2026
|
8 in 1 STI Test Kit
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0773-2026
|
Akkermansia Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0807-2026
|
Food Intolerance Test Medium
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0760-2026
|
Food Sensitivity Test Large
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0765-2026
|
Mycotoxin Panel Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0762-2026
|
Food Sensitivity Test Small
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0803-2026
|
Allergy test Small
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0794-2026
|
Peptic Ulcer Test (H, pylori)
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0809-2026
|
Heavy Metals Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0777-2026
|
Fructose Intolerance Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0753-2026
|
Trichomonas Vaginalis test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0796-2026
|
SIBO Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0785-2026
|
Intestinal Worms Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0731-2026
|
D-Dimer Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0732-2026
|
Diabetes HbA1c Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0729-2026
|
Candida Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0751-2026
|
Syphilis Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0810-2026
|
Iodine Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0745-2026
|
MPOX Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0763-2026
|
GI Microbiome Profile Small
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0748-2026
|
Parasite Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0757-2026
|
Sperm Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0776-2026
|
DHEA Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0815-2026
|
Serotonin Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0737-2026
|
Female Fertility Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0780-2026
|
Gut Microbiome Test Mega
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0759-2026
|
Food Allergy Panel Test (IgE)
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0806-2026
|
Food Intolerance Test Large
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0766-2026
|
NAD Profile Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0768-2026
|
Vitamin D2 and D3 Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0787-2026
|
Leaky Gut Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0800-2026
|
Kidney Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0816-2026
|
2 in 1 Trichomonas / Gardnerella Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0744-2026
|
Menopause (FSH) 2 Tests
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0728-2026
|
Blood Type Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0817-2026
|
3 in 1 STI Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0774-2026
|
Biological Age & Longevity Test
|
GET TESTED INTERNATIONAL AB | Class II | Ongoing |
Z-0858-2026
|
IntelliVue MP90. Product Number: M8010A.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0852-2026
|
IntelliVue MP30. Product Number: M8002A.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0869-2026
|
IntelliVue Patient Monitor MX800. Product Number: 865240.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0883-2026
|
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
|
Philips Ultrasound, LLC
|
Class II | Ongoing |
Z-0867-2026
|
IntelliVue Patient Monitor MX700. Product Number: 865241.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0864-2026
|
IntelliVue Patient Monitor MX500. Product Number: 866064.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0870-2026
|
IntelliVue Patient Monitor MX850. Product Number: 866470.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0601-2026
|
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shep…
|
Stryker Corporation
|
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 …
|
Stryker Corporation
|
Class II | Ongoing |
Z-0849-2026
|
IntelliVue MP2. Product Number: M8102A.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0854-2026
|
IntelliVue MP50. Product Number: M8004A.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0857-2026
|
IntelliVue MP80. Product Number: M8008A.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0861-2026
|
IntelliVue Patient Monitor MX100. Product Number: 867033.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0853-2026
|
IntelliVue MP40. Product Number: M8003A.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0872-2026
|
Olympus OER-Elite
|
Aizu Olympus Co., Ltd. | Class II | Ongoing |
Z-0859-2026
|
IntelliVue Multi Measurement Server X2. Product Number: M3002A.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0855-2026
|
IntelliVue MP60. Product Number: M8005A.
|
Philips North America Llc
|
Class II | Ongoing |
Z-1039-2026
|
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
|
Medicrea International | Class II | Ongoing |
Z-0882-2026
|
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
|
Philips North America Llc
|
Class II | Ongoing |
Z-0881-2026
|
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
|
Philips North America Llc
|
Class II | Ongoing |
Z-0726-2026
|
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product …
|
Medtronic, Inc.
|
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…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1140-2026
|
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedsid…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-1142-2026
|
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Moni…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-1151-2026
|
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Descript…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-1153-2026
|
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Mon…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-0878-2026
|
MAMMOMAT Inspiration;
|
Siemens Medical Solutions USA, Inc
|
Class II | Ongoing |
Z-1155-2026
|
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects ph…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-0879-2026
|
MAMMOMAT Fusion;
|
Siemens Medical Solutions USA, Inc
|
Class II | Ongoing |
Z-1149-2026
|
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX ser…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-1146-2026
|
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-1154-2026
|
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series …
|
Edan Diagnostics
|
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…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-1152-2026
|
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Mon…
|
Edan Diagnostics
|
Class II | Ongoing |
Z-1371-2026
|
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1378-2026
|
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1373-2026
|
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1381-2026
|
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1375-2026
|
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1377-2026
|
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1382-2026
|
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0594-2026
|
CareLink Clinic, REF: MMT-7350
|
Medtronic MiniMed, Inc.
|
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…
|
Mindray DS USA, Inc. dba Mindray North America
|
Class II | Ongoing |
Z-0539-2026
|
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
|
Medtronic Perfusion Systems
|
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…
|
Mindray DS USA, Inc. dba Mindray North America
|
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…
|
Mozarc Medical US LLC
|
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 …
|
Mozarc Medical US LLC
|
Class II | Ongoing |
Z-0582-2026
|
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
|
Straumann USA LLC
|
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…
|
Mozarc Medical US LLC
|
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…
|
Mozarc Medical US LLC
|
Class II | Ongoing |
Z-0504-2026
|
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
|
Becton Dickinson & Company
|
Class II | Ongoing |
Z-0871-2026
|
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
|
Paragon 28, Inc.
|
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…
|
MRIMed Inc.
|
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…
|
Myofunctional Research Company USA
|
Class II | Ongoing |
Z-0506-2026
|
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Co…
|
Thoratec LLC
|
Class II | Ongoing |
Z-0436-2026
|
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
|
B-K Medical A/S
|
Class II | Ongoing |
Z-0440-2026
|
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
|
B-K Medical A/S
|
Class II | Ongoing |
Z-0437-2026
|
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
|
B-K Medical A/S
|
Class II | Ongoing |
Z-0508-2026
|
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ …
|
Thoratec LLC
|
Class II | Ongoing |
Z-0507-2026
|
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Ki…
|
Thoratec LLC
|
Class II | Ongoing |
Z-0587-2026
|
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
|
Pivotal Health Solutions, Inc.
|
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…
|
B-K Medical A/S
|
Class II | Ongoing |
Z-0438-2026
|
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
|
B-K Medical A/S
|
Class II | Ongoing |
Z-0452-2026
|
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Prod…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0542-2026
|
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest…
|
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…
|
Philips Respironics, Inc.
|
Class II | Ongoing |
Z-0413-2026
|
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
|
Trividia Health, Inc.
|
Class II | Ongoing |
Z-0493-2026
|
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-0483-2026
|
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgi…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0492-2026
|
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci…
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-0491-2026
|
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-1489-2022
|
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model …
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1485-2022
|
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC…
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-1486-2022
|
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, M…
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-0509-2026
|
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
|
Medtronic Perfusion Systems
|
Class II | Ongoing |
Z-0466-2026
|
Radiography 7300 C; Model Number: 712037;
|
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…
|
Medline Industries, LP
|
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 …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0465-2026
|
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
|
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…
|
ENDOMAGNETICS LTD
|
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.…
|
Medline Industries, LP
|
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.…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0463-2026
|
Precision CRF; Model Number: 706400;
|
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.…
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0461-2026
|
ProxiDiagnost N90; Model Number: 706110;
|
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.…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0519-2026
|
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3)…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0525-2026
|
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
|
Medline Industries, LP
|
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.
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0514-2026
|
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0370-2026
|
BD Pyxis Pro MedStation Main, REF: 1155-00
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-0528-2026
|
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
|
Medline Industries, LP
|
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 …
|
Medline Industries, LP
|
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…
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-0523-2026
|
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, …
|
Medline Industries, LP
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0512-2026
|
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0369-2026
|
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-0511-2026
|
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0517-2026
|
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS86001…
|
Medline Industries, LP
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-0556-2026
|
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product …
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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 …
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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…
|
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 …
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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 …
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-0566-2026
|
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-0559-2026
|
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, …
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-0456-2026
|
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
|
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…
|
Synthes (USA) Products LLC
|
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 …
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-0555-2026
|
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-0565-2026
|
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-0554-2026
|
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog …
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
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…
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-0486-2026
|
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06…
|
Covidien, LP
|
Class II | Ongoing |
Z-0485-2026
|
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
|
Covidien, LP
|
Class II | Ongoing |
Z-0722-2026
|
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
|
DJO, LLC
|
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…
|
Aesculap Inc
|
Class II | Ongoing |
Z-0312-2026
|
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N…
|
Aesculap Inc
|
Class II | Ongoing |
Z-0235-2026
|
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog…
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-0237-2026
|
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. …
|
Becton Dickinson & Co.
|
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…
|
Total Joint Orthopedics, Inc.
|
Class II | Ongoing |
Z-0541-2026
|
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for us…
|
Beckman Coulter Inc.
|
Class II | Ongoing |
Z-0145-2026
|
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Soft…
|
Kico Knee Innovation Company | Class II | Ongoing |
Z-0216-2026
|
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-0208-2026
|
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque …
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0156-2026
|
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
|
GE Medical Systems, LLC
|
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…
|
B BRAUN MEDICAL INC
|
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…
|
Cardinal Health 200, LLC
|
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…
|
Cardinal Health 200, LLC
|
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.…
|
B BRAUN MEDICAL INC
|
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…
|
B BRAUN MEDICAL INC
|
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…
|
B BRAUN MEDICAL INC
|
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 …
|
B BRAUN MEDICAL INC
|
Class II | Ongoing |
Z-0209-2026
|
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem …
|
Cardinal Health 200, LLC
|
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 …
|
B BRAUN MEDICAL INC
|
Class II | Ongoing |
Z-0489-2026
|
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.…
|
Abbott Laboratories
|
Class II | Ongoing |
Z-0158-2026
|
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
|
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…
|
B BRAUN MEDICAL INC
|
Class II | Ongoing |
Z-0157-2026
|
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
|
GE Medical Systems, LLC
|
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…
|
B BRAUN MEDICAL INC
|
Class II | Ongoing |
Z-0124-2026
|
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY.…
|
B BRAUN MEDICAL INC
|
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…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0230-2026
|
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS20…
|
CPM Medical Consultants, LLC.
|
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…
|
Enterix, Inc.
|
Class II | Ongoing |
Z-0319-2026
|
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
|
Surgical Theater Inc
|
Class II | Ongoing |
Z-0325-2026
|
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
|
Surgical Theater Inc
|
Class II | Ongoing |
Z-0323-2026
|
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processin…
|
Surgical Theater Inc
|
Class II | Ongoing |
Z-0324-2026
|
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic a…
|
Surgical Theater Inc
|
Class II | Ongoing |
Z-0320-2026
|
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
|
Surgical Theater Inc
|
Class II | Ongoing |
Z-0321-2026
|
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radi…
|
Surgical Theater Inc
|
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…
|
Alcon Research LLC
|
Class II | Ongoing |
Z-0165-2026
|
Cardiac Workstation 5000; Model Number: 860439;
|
Philips North America
|
Class II | Ongoing |
Z-0589-2026
|
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicate…
|
Argon Medical Devices, Inc
|
Class II | Ongoing |
Z-0205-2026
|
Product: STA Liatest D-Di; REF: 00515;
|
Diagnostica Stago, Inc.
|
Class II | Ongoing |
Z-0234-2026
|
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syri…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-0133-2026
|
FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
|
Ferno-Washington Inc
|
Class II | Ongoing |
Z-0139-2026
|
TENACIO Pump without InhibiZone; UPN: 72404420;
|
Boston Scientific Corporation
|
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-…
|
Theken Companies LLC
|
Class II | Ongoing |
Z-0138-2026
|
TENACIO Pump with InhibiZone; UPN: 72404429;
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0141-2026
|
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
|
Boston Scientific Corporation
|
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…
|
MedicalCommunications GmbH
|
Class II | Ongoing |
Z-2619-2025
|
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
|
Biomet, Inc.
|
Class II | Ongoing |
Z-0348-2026
|
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0357-2026
|
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0330-2026
|
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0364-2026
|
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0356-2026
|
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0354-2026
|
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0329-2026
|
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0351-2026
|
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0353-2026
|
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
|
ICU Medical, Inc.
|
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…
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0365-2026
|
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
|
ICU Medical, Inc.
|
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…
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-0337-2026
|
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
|
ICU Medical, Inc.
|
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, …
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0347-2026
|
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0352-2026
|
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0331-2026
|
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0350-2026
|
ICU Medical ChemoLock Port REF: CL2100
|
ICU Medical, Inc.
|
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…
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0342-2026
|
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0363-2026
|
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
|
ICU Medical, Inc.
|
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…
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0341-2026
|
ICU Medical ChemoLock Bag Spike REF: CL-10
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0336-2026
|
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0346-2026
|
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
|
ICU Medical, Inc.
|
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
|
ICU Medical, Inc.
|
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…
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0349-2026
|
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0361-2026
|
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-0135-2026
|
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microi…
|
Iantrek Inc.
|
Class II | Ongoing |
Z-0134-2026
|
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinter…
|
Iantrek Inc.
|
Class II | Ongoing |
Z-0068-2026
|
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
|
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…
|
Spacelabs Healthcare, Inc.
|
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…
|
Spacelabs Healthcare, Inc.
|
Class II | Ongoing |
Z-0180-2026
|
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN…
|
American Contract Systems Inc.
|
Class II | Ongoing |
Z-0185-2026
|
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17…
|
American Contract Systems Inc.
|
Class II | Ongoing |
Z-0174-2026
|
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC…
|
American Contract Systems Inc.
|
Class II | Ongoing |
Z-0173-2026
|
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL…
|
American Contract Systems Inc.
|
Class II | Ongoing |
Z-0187-2026
|
Medical convenience kits IHDC30R D AND C PACK
|
American Contract Systems Inc.
|
Class II | Ongoing |
Z-0170-2026
|
Basic Biopsy Tray, Item Number NMBP44L
|
American Contract Systems Inc.
|
Class II | Ongoing |
Z-0184-2026
|
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15…
|
American Contract Systems Inc.
|
Class II | Ongoing |
Z-0171-2026
|
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PAC…
|
American Contract Systems Inc.
|
Class II | Ongoing |
Z-2627-2025
|
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-2633-2025
|
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-2634-2025
|
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0010-2026
|
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, …
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0009-2026
|
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, …
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0013-2026
|
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, …
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0004-2026
|
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-2635-2025
|
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0001-2026
|
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-2623-2025
|
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0014-2026
|
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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,…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0006-2026
|
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0012-2026
|
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, …
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-2631-2025
|
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0015-2026
|
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0011-2026
|
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, …
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-0378-2026
|
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
|
Fresenius Kabi USA, LLC
|
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…
|
LeMaitre Vascular, Inc.
|
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 …
|
Berkeley Advanced Biomaterials, LLC
|
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…
|
Baxter Healthcare Corporation
|
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…
|
Northeast Scientific Inc.
|
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-…
|
Northeast Scientific Inc.
|
Class II | Ongoing |
Z-0194-2026
|
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0195-2026
|
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck…
|
Baxter Healthcare Corporation
|
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…
|
Northeast Scientific Inc.
|
Class II | Ongoing |
Z-0016-2026
|
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
|
Getinge Disinfection Ab
|
Class II | Ongoing |
Z-0198-2026
|
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable …
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0193-2026
|
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0202-2026
|
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0204-2026
|
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0038-2026
|
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultra…
|
ImaCor Inc.
|
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-…
|
Northeast Scientific Inc.
|
Class II | Ongoing |
Z-0203-2026
|
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micro…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0189-2026
|
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extensio…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0197-2026
|
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0200-2026
|
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer…
|
Baxter Healthcare Corporation
|
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…
|
Northeast Scientific Inc.
|
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…
|
Northeast Scientific Inc.
|
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…
|
Northeast Scientific Inc.
|
Class II | Ongoing |
Z-2606-2025
|
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Si…
|
CooperVision, Inc.
|
Class II | Ongoing |
Z-0231-2026
|
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu…
|
GE Medical Systems, LLC
|
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,…
|
CooperVision, Inc.
|
Class II | Ongoing |
Z-2585-2025
|
i-STAT EG6+ cartridge. List Number: 03P77-25.
|
Abbott Point Of Care Inc.
|
Class II | Ongoing |
Z-2576-2025
|
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
|
Folsom Metal Products, Inc.
|
Class II | Ongoing |
Z-2578-2025
|
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
|
Folsom Metal Products, Inc.
|
Class II | Ongoing |
Z-2582-2025
|
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
|
Abbott Point Of Care Inc.
|
Class II | Ongoing |
Z-2581-2025
|
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
|
Folsom Metal Products, Inc.
|
Class II | Ongoing |
Z-2583-2025
|
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
|
Abbott Point Of Care Inc.
|
Class II | Ongoing |
Z-2577-2025
|
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
|
Folsom Metal Products, Inc.
|
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
|
MicroSurgical Technology Inc
|
Class II | Ongoing |
Z-2550-2025
|
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-0…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0039-2026
|
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
|
CORNEAT VISION, LTD. | Class II | Ongoing |
Z-2551-2025
|
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
|
Boston Scientific Corporation
|
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…
|
CORNEAT VISION, LTD. | Class II | Ongoing |
Z-2586-2025
|
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
|
Maquet Cardiovascular, LLC
|
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…
|
Exactech, Inc.
|
Class II | Ongoing |
Z-2587-2025
|
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
|
Maquet Cardiovascular, LLC
|
Class II | Ongoing |
Z-2622-2025
|
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00…
|
Mindray DS USA, Inc. dba Mindray North America
|
Class II | Ongoing |
Z-1276-2022
|
Clean Catch Urine Kit NS 178489, AHMU58A
|
American Contract Systems, Inc.
|
Class I | Ongoing |
Z-1277-2022
|
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
|
American Contract Systems, Inc.
|
Class I | Ongoing |
Z-2574-2025
|
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
|
Beckman Coulter Inc.
|
Class II | Ongoing |
Z-0030-2026
|
Change Healthcare Radiology Solutions software version 14.2.2
|
CHANGE HEALTHCARE CANADA COMPANY
|
Class II | Ongoing |
Z-2598-2025
|
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
|
Philips North America Llc
|
Class II | Ongoing |
Z-1809-2026
|
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
|
Beta Bionics, Inc.
|
Class II | Ongoing |
Z-2601-2025
|
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
Class II | Ongoing |
Z-2603-2025
|
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
|
Philips North America Llc
|
Class II | Ongoing |
Z-2572-2025
|
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
|
Beckman Coulter Inc.
|
Class II | Ongoing |
Z-2604-2025
|
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
Class II | Ongoing |
Z-2595-2025
|
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT …
|
Philips North America Llc
|
Class II | Ongoing |
Z-2573-2025
|
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
|
Beckman Coulter Inc.
|
Class II | Ongoing |
Z-2575-2025
|
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
|
Beckman Coulter Inc.
|
Class II | Ongoing |
Z-2529-2025
|
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
|
Siemens Medical Solutions USA, Inc
|
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…
|
Agilent Technologies Denmark ApS
|
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…
|
Agilent Technologies Denmark ApS
|
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…
|
Agilent Technologies Denmark ApS
|
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…
|
Merge Healthcare, Inc.
|
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 …
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-2492-2025
|
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStatio…
|
RAYSEARCH LABORATORIES AB
|
Class II | Ongoing |
Z-2488-2025
|
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8…
|
RAYSEARCH LABORATORIES AB
|
Class II | Ongoing |
Z-2543-2025
|
IntelliSpace Cardiovascular, Software 8.0.0.4.
|
Philips Medical Systems Nederland B.V.
|
Class II | Ongoing |
Z-2672-2025
|
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
|
Schiller, Ag
|
Class II | Ongoing |
Z-2491-2025
|
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStatio…
|
RAYSEARCH LABORATORIES AB
|
Class II | Ongoing |
Z-2489-2025
|
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation …
|
RAYSEARCH LABORATORIES AB
|
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.…
|
RAYSEARCH LABORATORIES AB
|
Class II | Ongoing |
Z-2490-2025
|
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStatio…
|
RAYSEARCH LABORATORIES AB
|
Class II | Ongoing |
Z-2493-2025
|
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStati…
|
RAYSEARCH LABORATORIES AB
|
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…
|
Maquet Cardiovascular, LLC
|
Class II | Ongoing |
Z-2554-2025
|
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
|
SEASPINE ORTHOPEDICS CORPORATION
|
Class II | Ongoing |
Z-2505-2025
|
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Pa…
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-0305-2026
|
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod…
|
Alcon Research LLC
|
Class II | Ongoing |
Z-0232-2026
|
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, a…
|
Tandem Diabetes Care, Inc.
|
Class II | Ongoing |
Z-2570-2025
|
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)008…
|
Philips Medical Systems (Cleveland) Inc
|
Class II | Ongoing |
Z-2512-2025
|
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infu…
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-0307-2026
|
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod…
|
Alcon Research LLC
|
Class II | Ongoing |
Z-2508-2025
|
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P…
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-0306-2026
|
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod…
|
Alcon Research LLC
|
Class II | Ongoing |
Z-2530-2025
|
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
|
AVID Medical, Inc.
|
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…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
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 …
|
Lumicell, Inc.
|
Class II | Ongoing |
Z-2337-2025
|
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
|
Mckesson Medical-Surgical Inc. Corporate Office
|
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…
|
S.I.N. Implant System Ltda
|
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 …
|
Ortho-Clinical Diagnostics, Inc.
|
Class II | Ongoing |
Z-2615-2025
|
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 …
|
ORTOMA AB
|
Class II | Ongoing |
Z-2338-2025
|
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SE…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-2639-2025
|
ZAP-X Radiosurgery System, Model: 300150
|
Zap Surgical Systems
|
Class II | Ongoing |
Z-2553-2025
|
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /…
|
Merit Medical Systems, Inc.
|
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…
|
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…
|
Dentsply IH, Inc.
|
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…
|
Dentsply IH, Inc.
|
Class II | Ongoing |
Z-2417-2025
|
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: Th…
|
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…
|
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…
|
THOR Photomedicine Ltd | Class II | Ongoing |
Z-1045-2022
|
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
|
Woodside Acquisitions Inc.
|
Class I | Ongoing |
Z-2292-2025
|
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive d…
|
Trinity Biotech USA
|
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…
|
Physio-Control, Inc.
|
Class II | Ongoing |
Z-1044-2022
|
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
|
Woodside Acquisitions Inc.
|
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…
|
Physio-Control, Inc.
|
Class II | Ongoing |
Z-2486-2025
|
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 …
|
Reflexion Medical, Inc.
|
Class II | Ongoing |
Z-2498-2025
|
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000…
|
Physio-Control, Inc.
|
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…
|
Diagnostica Stago, Inc.
|
Class II | Ongoing |
Z-2473-2025
|
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop a…
|
Diagnostica Stago, Inc.
|
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, …
|
Diagnostica Stago, Inc.
|
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…
|
Diagnostica Stago, Inc.
|
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…
|
Encore Medical, LP
|
Class II | Ongoing |
Z-2549-2025
|
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version…
|
Encore Medical, LP
|
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…
|
Encore Medical, LP
|
Class II | Ongoing |
Z-2548-2025
|
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 …
|
Encore Medical, LP
|
Class II | Ongoing |
Z-2589-2025
|
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
|
C.R. Bard Inc
|
Class II | Ongoing |
Z-2590-2025
|
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
|
C.R. Bard Inc
|
Class II | Ongoing |
Z-2552-2025
|
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 0…
|
Quest International, Inc.
|
Class II | Ongoing |
Z-2620-2025
|
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
|
Stryker Communications
|
Class II | Ongoing |
Z-2288-2025
|
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-2420-2025
|
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F…
|
MAQUET GMBH | Class II | Ongoing |
Z-2223-2025
|
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
|
Remel, Inc
|
Class II | Ongoing |
Z-2226-2025
|
Blood/MacConkey Biplate 100/PK, Product Number R02049
|
Remel, Inc
|
Class II | Ongoing |
Z-2224-2025
|
Strep Selective II Agar, Product Number R01859
|
Remel, Inc
|
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…
|
Biofire Defense
|
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…
|
Encore Medical, LP
|
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…
|
Encore Medical, LP
|
Class II | Ongoing |
Z-2452-2025
|
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utili…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-2340-2025
|
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimu…
|
Boston Scientific Neuromodulation Corporation
|
Class II | Ongoing |
Z-2558-2025
|
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
|
Boston Scientific Neuromodulation Corporation
|
Class II | Ongoing |
Z-2237-2025
|
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
|
Becton, Dickinson and Company, BD Bio Sciences
|
Class II | Ongoing |
Z-2238-2025
|
BD Trucount Controls, 30 Test - REF: 340335
|
Becton, Dickinson and Company, BD Bio Sciences
|
Class II | Ongoing |
Z-2272-2025
|
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
|
Siemens Healthcare Diagnostics Inc
|
Class II | Ongoing |
Z-2442-2025
|
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head …
|
Orascoptic Surgical Acuity
|
Class II | Ongoing |
Z-2445-2025
|
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
|
Orascoptic Surgical Acuity
|
Class II | Ongoing |
Z-2444-2025
|
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
|
Orascoptic Surgical Acuity
|
Class II | Ongoing |
Z-2342-2025
|
GE HealthCare OEC 9900 Elite C-arm Systems.
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-2341-2025
|
GE HealthCare OEC 9800.
|
GE Medical Systems, LLC
|
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
|
Spark Biomedical Inc
|
Class II | Ongoing |
Z-2637-2025
|
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Mod…
|
North American Rescue LLC.
|
Class II | Ongoing |
Z-2282-2025
|
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray D…
|
Carefree Surgical Specialties
|
Class II | Ongoing |
Z-2284-2025
|
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-…
|
Carefree Surgical Specialties
|
Class II | Ongoing |
Z-2283-2025
|
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray D…
|
Carefree Surgical Specialties
|
Class II | Ongoing |
Z-2281-2025
|
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectab…
|
Carefree Surgical Specialties
|
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 …
|
SPINEART SA
|
Class II | Ongoing |
Z-2211-2025
|
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
|
Philips North America
|
Class II | Ongoing |
Z-2215-2025
|
SmartPath to dStream for 3.0T Model Number (REF): 782145;
|
Philips North America
|
Class II | Ongoing |
Z-2205-2025
|
Ingenia 1.5T S Model Number (REF): 781347;
|
Philips North America
|
Class II | Ongoing |
Z-2206-2025
|
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
|
Philips North America
|
Class II | Ongoing |
Z-2213-2025
|
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
|
Philips North America
|
Class II | Ongoing |
Z-2208-2025
|
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
|
Philips North America
|
Class II | Ongoing |
Z-2200-2025
|
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
|
Philips North America
|
Class II | Ongoing |
Z-2218-2025
|
Upgrade to MR 7700 Model Number (REF): 782130;
|
Philips North America
|
Class II | Ongoing |
Z-2112-2025
|
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
|
Beyond Laser Systems, LLC
|
Class II | Ongoing |
Z-2207-2025
|
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
|
Philips North America
|
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 …
|
SPINEART SA
|
Class II | Ongoing |
Z-2210-2025
|
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
|
Philips North America
|
Class II | Ongoing |
Z-2111-2025
|
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
|
Beyond Laser Systems, LLC
|
Class II | Ongoing |
Z-2201-2025
|
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
|
Philips North America
|
Class II | Ongoing |
Z-2217-2025
|
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
|
Philips North America
|
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…
|
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…
|
HeartSine Technologies Ltd | Class II | Ongoing |
Z-2203-2025
|
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
|
Philips North America
|
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)
|
Microbiologics Inc
|
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; …
|
Spiggle & Theis Mt Gmbh
|
Class II | Ongoing |
Z-2230-2025
|
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
|
Siemens Healthcare Diagnostics Inc
|
Class II | Ongoing |
Z-2267-2025
|
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-2271-2025
|
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-2268-2025
|
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-2278-2025
|
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-2270-2025
|
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
|
Beckman Coulter, Inc.
|
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-…
|
Fresenius Kabi USA, LLC
|
Class II | Ongoing |
Z-2555-2025
|
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
|
Orthofix U.S. LLC
|
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.
|
Fresenius Kabi USA, LLC
|
Class II | Ongoing |
Z-2178-2025
|
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
|
Steris Corporation
|
Class II | Ongoing |
Z-2177-2025
|
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
|
Steris Corporation
|
Class II | Ongoing |
Z-2168-2025
|
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt …
|
Medtronic, Inc.
|
Class II | Ongoing |
Z-2171-2025
|
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
|
Stryker Corporation
|
Class II | Ongoing |
Z-2169-2025
|
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr…
|
Medtronic, Inc.
|
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. …
|
Osteotec Limited | Class II | Ongoing |
Z-2545-2025
|
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
|
Quidel Corporation
|
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…
|
CARIS LIFE SCIENCES
|
Class II | Ongoing |
Z-2165-2025
|
Biofinity XR Toric Contact Lens
|
CooperVision, Inc.
|
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…
|
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…
|
Atrium Medical Corporation
|
Class I | Ongoing |
Z-1077-2022
|
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 …
|
Atrium Medical Corporation
|
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…
|
Volcano Corp
|
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…
|
Ortho-Clinical Diagnostics, Inc.
|
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,…
|
RECORDATI RARE DISEASES INC.
|
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.
|
CooperSurgical, Inc.
|
Class II | Ongoing |
Z-2219-2025
|
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt…
|
FUJIFILM Healthcare Americas Corporation
|
Class II | Ongoing |
Z-2190-2025
|
BostonSight SCLERAL Lens
|
Boston Foundation For Sight
|
Class II | Ongoing |
Z-2191-2025
|
BostonSight PROSE Lens.
|
Boston Foundation For Sight
|
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 …
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-2103-2025
|
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (18…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-2105-2025
|
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACRO…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-2120-2025
|
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Num…
|
Ortho-Clinical Diagnostics, Inc.
|
Class II | Ongoing |
Z-2121-2025
|
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu…
|
Ortho-Clinical Diagnostics, Inc.
|
Class II | Ongoing |
Z-2485-2025
|
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect …
|
Boston Scientific Neuromodulation Corporation
|
Class II | Ongoing |
Z-2119-2025
|
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A P…
|
Waismed Ltd.
|
Class II | Ongoing |
Z-2118-2025
|
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A …
|
Waismed Ltd.
|
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…
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-2294-2025
|
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-1982-2025
|
UROSKOP Omnia Max. Model Number: 10762473
|
Siemens Medical Solutions USA, Inc
|
Class II | Ongoing |
Z-2089-2025
|
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-2088-2025
|
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-2134-2025
|
Azurion 7 M20. Fluoroscopic X-Ray System.
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
|
Class II | Ongoing |
Z-2116-2025
|
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200…
|
ICU Medical, Inc.
|
Class II | Ongoing |
Z-2076-2025
|
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
|
C.R. Bard Inc
|
Class II | Ongoing |
Z-2074-2025
|
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr …
|
C.R. Bard Inc
|
Class II | Ongoing |
Z-2513-2025
|
Medshape Universal Joints, REF: DNE-9000-UJ
|
Medshape, INC.
|
Class II | Ongoing |
Z-1931-2025
|
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
|
Philips North America
|
Class II | Ongoing |
Z-1932-2025
|
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
|
Philips North America
|
Class II | Ongoing |
Z-1936-2025
|
SmartPath to dStream for 1.5T¿; Product Number: 782146;
|
Philips North America
|
Class II | Ongoing |
Z-1929-2025
|
Intera 1.5T Achieva IT Nova Product Number: 781175
|
Philips North America
|
Class II | Ongoing |
Z-2053-2025
|
Philips eL18-4 EMT Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2051-2025
|
Philips C9-5EC Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2052-2025
|
Philips eL18-4 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2050-2025
|
Philips C5-2 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2054-2025
|
Philips L12-3 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2065-2025
|
Philips X6-1 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2067-2025
|
Philips X8-2t Transducer.
|
Philips Ultrasound, Inc
|
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…
|
Terumo Cardiovascular Systems Corporation
|
Class II | Ongoing |
Z-2062-2025
|
Philips V6-2 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2058-2025
|
Philips S5-1 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2059-2025
|
Philips S7-2 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2048-2025
|
Philips 3D9-3v Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2066-2025
|
Philips X7-2t Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2064-2025
|
Philips X5-1 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2061-2025
|
Philips S8-3t Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2068-2025
|
Philips XL14-3 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2049-2025
|
Philips C5-1 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-2055-2025
|
Philips L12-4 Transducer.
|
Philips Ultrasound, Inc
|
Class II | Ongoing |
Z-1914-2025
|
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
|
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…
|
Microbiologics Inc
|
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…
|
CORIN MEDICAL, LTD. | Class II | Ongoing |
Z-2130-2025
|
SIGNA Architect
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-1927-2025
|
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory int…
|
QUANTUM SURGICAL SAS | Class II | Ongoing |
Z-2131-2025
|
SIGNA Architect AIR
|
GE Medical Systems, LLC
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-2072-2025
|
Change Healthcare Cardiology Hemodynamics Software
|
CHANGE HEALTHCARE CANADA COMPANY | Class II | Ongoing |
Z-1939-2025
|
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
|
Stryker GmbH | Class II | Ongoing |
Z-2071-2025
|
Change Healthcare Cardiology Hemo Software
|
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
|
Becton Dickinson Infusion Therapy Systems, Inc.
|
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…
|
Becton Dickinson Infusion Therapy Systems, Inc.
|
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
|
Becton Dickinson Infusion Therapy Systems, Inc.
|
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
|
Becton Dickinson Infusion Therapy Systems, Inc.
|
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
|
Becton Dickinson Infusion Therapy Systems, Inc.
|
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,…
|
Becton Dickinson Infusion Therapy Systems, Inc.
|
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
|
Becton Dickinson Infusion Therapy Systems, Inc.
|
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…
|
Becton Dickinson Infusion Therapy Systems, Inc.
|
Class II | Ongoing |
Z-2023-2025
|
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cul…
|
Becton Dickinson & Co.
|
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…
|
Onkos Surgical, Inc.
|
Class II | Ongoing |
Z-2025-2025
|
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
|
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…
|
Drs Vascular, Inc
|
Class II | Ongoing |
Z-1822-2026
|
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software …
|
THERAKOS DEVELOPMENT LIMITED
|
Class II | Ongoing |
Z-1995-2025
|
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1956-2025
|
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
|
Contamac Solutions, Inc.
|
Class II | Ongoing |
Z-1794-2025
|
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1800-2025
|
Product Name: Ingenia 3.0T CX; Model Number: 781271;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1799-2025
|
Product Name: Ingenia 1.5T CX; Model Number: 781262;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1805-2025
|
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1803-2025
|
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1797-2025
|
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1796-2025
|
Product Name: Ingenia 1.5T S; Model Number: 781347;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1789-2025
|
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
|
Philips North America Llc
|
Class II | Ongoing |
Z-1801-2025
|
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1802-2025
|
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1791-2025
|
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1798-2025
|
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
|
Philips North America Llc
|
Class II | Ongoing |
Z-1973-2025
|
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
|
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…
|
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:…
|
BD SWITZERLAND SARL | Class II | Ongoing |
Z-1964-2025
|
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1974-2025
|
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
|
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…
|
BD SWITZERLAND SARL | Class II | Ongoing |
Z-1962-2025
|
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-2039-2025
|
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S…
|
Ortho-Clinical Diagnostics, Inc.
|
Class II | Ongoing |
Z-0663-2022
|
Philips Respironics V60 Plus Ventilator Part Number 1138747
|
Respironics California, LLC
|
Class I | Ongoing |
Z-1980-2025
|
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
|
Ohio Medical Corporation
|
Class II | Ongoing |
Z-0662-2022
|
Philips Respironics V60 Ventilator Part Number 1053617
|
Respironics California, LLC
|
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…
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-1925-2025
|
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/…
|
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…
|
MicroAire Surgical Instruments, LLC
|
Class II | Ongoing |
Z-1922-2025
|
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalo…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1812-2025
|
PhenoMATRIX
|
Copan WASP
|
Class II | Ongoing |
Z-1816-2025
|
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1911-2025
|
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1906-2025
|
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syste…
|
Dexcom, Inc.
|
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…
|
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
|
Class II | Ongoing |
Z-1870-2025
|
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-1910-2025
|
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
|
Healthmark Industries Co., Inc.
|
Class II | Ongoing |
Z-1871-2025
|
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-1937-2025
|
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
|
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…
|
Remel, Inc
|
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…
|
Implant Direct Sybron Manufacturing LLC
|
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 …
|
Beckman Coulter Mishima K.K.
|
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 …
|
Beckman Coulter Mishima K.K.
|
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 …
|
Abbott Molecular, Inc.
|
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 (…
|
Abbott Molecular, Inc.
|
Class II | Ongoing |
Z-2108-2025
|
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog …
|
Alcon Research LLC
|
Class II | Ongoing |
Z-1955-2025
|
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No …
|
Tecfen Medical
|
Class II | Ongoing |
Z-1954-2025
|
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software …
|
Tecfen Medical
|
Class II | Ongoing |
Z-1949-2025
|
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No soft…
|
Tecfen Medical
|
Class II | Ongoing |
Z-1952-2025
|
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No …
|
Tecfen Medical
|
Class II | Ongoing |
Z-1854-2025
|
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1846-2025
|
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1836-2025
|
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1837-2025
|
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1965-2025
|
iBOT PMD with software version 01.05.24. Personal Mobility Device.
|
Mobius Mobility LLC
|
Class II | Ongoing |
Z-1842-2025
|
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1851-2025
|
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1850-2025
|
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1843-2025
|
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1825-2025
|
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1855-2025
|
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1831-2025
|
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1840-2025
|
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1828-2025
|
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1847-2025
|
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1838-2025
|
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1844-2025
|
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1827-2025
|
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
|
Mckesson Medical-Surgical Inc. Corporate Office
|
Class II | Ongoing |
Z-1885-2025
|
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
|
Mozarc Medical US LLC
|
Class II | Ongoing |
Z-1886-2025
|
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
|
Mozarc Medical US LLC
|
Class II | Ongoing |
Z-1913-2025
|
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-1887-2025
|
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
|
Mozarc Medical US LLC
|
Class II | Ongoing |
Z-1889-2025
|
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
|
Mozarc Medical US LLC
|
Class II | Ongoing |
Z-2231-2025
|
3M Ranger Irrigation Fluid Warming Set, REF 24750
|
3M Company
|
Class II | Ongoing |
Z-1858-2025
|
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (…
|
C-RAD POSITIONING AB
|
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…
|
Cook Incorporated
|
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…
|
Cook Incorporated
|
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
|
Remote Diagnostic Technologies Ltd.
|
Class II | Ongoing |
Z-1821-2025
|
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-1822-2025
|
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
|
Siemens Healthcare Diagnostics, Inc.
|
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…
|
Prismatik Dentalcraft, Inc.
|
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…
|
Ortho-Clinical Diagnostics, Inc.
|
Class II | Ongoing |
Z-1738-2025
|
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
|
Tornier S.A.S.
|
Class II | Ongoing |
Z-1766-2025
|
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1747-2025
|
FoundationOne Companion Diagnostic (F1CDx)
|
Foundation Medicine, Inc.
|
Class II | Ongoing |
Z-1728-2025
|
Artix MT Thrombectomy Device, REF: 32-102
|
Inari Medical - Oak Canyon
|
Class II | Ongoing |
Z-2028-2025
|
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4…
|
Beckman Coulter Inc.
|
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…
|
Philips North America Llc
|
Class II | Ongoing |
Z-1740-2025
|
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
|
Philips Medical Systems Nederland B.V.
|
Class II | Ongoing |
Z-1718-2025
|
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
|
SCIENCE & BIO MATERIALS
|
Class II | Ongoing |
Z-0493-2022
|
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous …
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-0494-2022
|
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides …
|
Philips Respironics, Inc.
|
Class I | Ongoing |
Z-1724-2025
|
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
|
Integra LifeSciences Corp. (NeuroSciences)
|
Class II | Ongoing |
Z-1715-2025
|
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-1769-2025
|
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F …
|
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)…
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
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-…
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-1704-2025
|
Enhanced Verify Evaluation Handset (CFN HH90130FA)
|
Medtronic Neuromodulation
|
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…
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-1721-2025
|
Washer Disinfector Aquadis 56; Model Number: 56M
|
Getinge Disinfection Ab
|
Class II | Ongoing |
Z-1720-2025
|
Washer Disinfector Aquadis 56; Model Number: 56A
|
Getinge Disinfection Ab
|
Class II | Ongoing |
Z-1703-2025
|
myQA iON; Article Number: MQ10-000;
|
IBA Dosimetry GmbH
|
Class II | Ongoing |
Z-1660-2025
|
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
|
Philips North America Llc
|
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…
|
Belmont Instrument LLC
|
Class II | Ongoing |
Z-1741-2025
|
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-1859-2025
|
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning…
|
Ultra Clean Systems, Inc.
|
Class II | Ongoing |
Z-1743-2025
|
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-1674-2025
|
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperth…
|
Belmont Instrument LLC
|
Class II | Ongoing |
Z-1734-2025
|
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position …
|
Galt Medical Corporation
|
Class II | Ongoing |
Z-1663-2025
|
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
|
IHB OPERATIONS B.V.
|
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…
|
Galt Medical Corporation
|
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…
|
Galt Medical Corporation
|
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 …
|
Conformis Inc.
|
Class II | Ongoing |
Z-1776-2025
|
Intera 1.5T Master/Nova, Model Number: 781106;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1558-2025
|
Welch Allyn Connex Vital Signs Monitor (CVSM):
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1783-2025
|
SmartPath to dStream for 3.0T, Model Number: 782145;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1775-2025
|
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1559-2025
|
Welch Allyn CONNEX Accessory Power Management Stand:
|
Baxter Healthcare Corporation
|
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…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-1782-2025
|
SmartPath to dStream for 1.5T, Model Number: 782146;
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1772-2025
|
Intera 1.0T Omni/Stellar, Model Number: 781102;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1719-2025
|
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1770-2025
|
Enterprise 1.5T, Model Number: 781145;
|
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 …
|
Boston Scientific Corporation
|
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…
|
Zimmer, Inc.
|
Class II | Ongoing |
Z-1777-2025
|
Intera 1.5T Omni/Stellar, Model Number: 781104;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1771-2025
|
Intera 0.5T Standard, Model Number: 781101;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1780-2025
|
Intera 3.0T Quasar Dual, Model Number: 781150;
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1778-2025
|
Intera 1.5T Power/Pulsar, Model Number: 781105;
|
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…
|
Abbott Molecular, Inc.
|
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…
|
Maquet Cardiovascular, LLC
|
Class II | Ongoing |
Z-1707-2025
|
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1709-2025
|
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1706-2025
|
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1705-2025
|
Medline Sterile Water, USP, 100mL, REF RDI30295
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1712-2025
|
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
Siemens Healthcare Diagnostics Inc
|
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…
|
Abbott Laboratories
|
Class II | Ongoing |
Z-1806-2025
|
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
|
Smith & Nephew, Inc.
|
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…
|
Abbott Laboratories
|
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…
|
Abbott Laboratories
|
Class II | Ongoing |
Z-1643-2025
|
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
|
Abbott
|
Class II | Ongoing |
Z-1672-2025
|
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 …
|
Beckman Coulter Inc.
|
Class II | Ongoing |
Z-1644-2025
|
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
|
Abbott
|
Class II | Ongoing |
Z-1860-2025
|
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
|
Pro-Med Instruments Gmbh
|
Class II | Ongoing |
Z-1640-2025
|
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-1641-2025
|
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca…
|
Merit Medical Systems, Inc.
|
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…
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-1551-2025
|
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-1554-2025
|
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
|
Philips North America Llc
|
Class II | Ongoing |
Z-1513-2025
|
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
|
Ethicon Endo Surgery, LLC
|
Class II | Ongoing |
Z-1515-2025
|
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
|
Ethicon Endo Surgery, LLC
|
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…
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-1548-2025
|
MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1547-2025
|
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
Abbott Diagnostics Scarborough, Inc.
|
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…
|
Abbott Diagnostics Scarborough, Inc.
|
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…
|
Abbott Diagnostics Scarborough, Inc.
|
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…
|
Abbott Diagnostics Scarborough, Inc.
|
Class II | Ongoing |
Z-1543-2025
|
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P…
|
Medtronic Neuromodulation
|
Class II | Ongoing |
Z-1605-2025
|
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1618-2025
|
Refer to RES
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1612-2025
|
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
|
MEDLINE INDUSTRIES, LP - Northfield
|
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 …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1587-2025
|
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1611-2025
|
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAG…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1595-2025
|
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Mod…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1601-2025
|
Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1610-2025
|
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1606-2025
|
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1403-2025
|
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No…
|
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
|
Class II | Ongoing |
Z-1589-2025
|
Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1619-2025
|
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHR…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1590-2025
|
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOG…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1593-2025
|
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1600-2025
|
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1500-2025
|
Phoroptor VRx Digital Refraction System Model Numbers: 16241
|
Reichert, Inc.
|
Class II | Ongoing |
Z-1501-2025
|
Phoroptor VRx Digital Refraction System Model Numbers: 16242
|
Reichert, Inc.
|
Class II | Ongoing |
Z-1408-2025
|
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
|
Premier Dental Products Co
|
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…
|
Intuitive Surgical, Inc.
|
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
|
Stryker Corporation
|
Class II | Ongoing |
Z-1476-2025
|
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
|
Stryker Corporation
|
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
|
Stryker Corporation
|
Class II | Ongoing |
Z-1477-2025
|
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
|
Stryker Corporation
|
Class II | Ongoing |
Z-1419-2025
|
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1482-2025
|
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
|
Stryker Corporation
|
Class II | Ongoing |
Z-1413-2025
|
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1471-2025
|
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
|
Stryker Corporation
|
Class II | Ongoing |
Z-1422-2025
|
Baxter TruSystem 7500, Product Code 4091000
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1410-2025
|
Baxter Stationary column TruSystem 7500, Product Code 1717020
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1416-2025
|
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1418-2025
|
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
|
Baxter Healthcare Corporation
|
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…
|
Stryker Corporation
|
Class II | Ongoing |
Z-1473-2025
|
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
|
Stryker Corporation
|
Class II | Ongoing |
Z-1470-2025
|
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
|
Stryker Corporation
|
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…
|
Stryker Corporation
|
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…
|
Stryker Corporation
|
Class II | Ongoing |
Z-1474-2025
|
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
|
Stryker Corporation
|
Class II | Ongoing |
Z-1466-2025
|
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model…
|
Checkpoint Surgical Inc
|
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…
|
Medtronic Navigation, Inc.
|
Class I | Ongoing |
Z-1432-2025
|
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: …
|
Orthofix U.S. LLC
|
Class II | Ongoing |
Z-1371-2025
|
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control…
|
Microbiologics Inc
|
Class II | Ongoing |
Z-1454-2025
|
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed qu…
|
Microbiologics Inc
|
Class II | Ongoing |
Z-1267-2025
|
MIM software; System, Image Processing, Radiological
|
MIM Software Inc
|
Class II | Ongoing |
Z-1531-2025
|
Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOL…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1378-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediat…
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-1385-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated…
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-0396-2026
|
Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-1377-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Se…
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-1379-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampli…
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-0393-2026
|
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0379-2026
|
9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0397-2026
|
Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0381-2026
|
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-1384-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated…
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-0399-2026
|
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0385-2026
|
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0404-2026
|
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-1380-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - …
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-1383-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad…
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-0405-2026
|
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0400-2026
|
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0386-2026
|
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0406-2026
|
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0389-2026
|
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-1382-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intub…
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-0394-2026
|
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0398-2026
|
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-1381-2025
|
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediat…
|
Oridion Medical 1987 Ltd.
|
Class II | Ongoing |
Z-0391-2026
|
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-0407-2026
|
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
|
DAYE (ANNE'S DAY LTD)
|
Class II | Ongoing |
Z-1372-2025
|
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-1404-2025
|
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
|
Smiths Medical ASD, Inc.
|
Class II | Ongoing |
Z-1374-2025
|
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Class II | Ongoing |
Z-1405-2025
|
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
|
Smiths Medical ASD, Inc.
|
Class II | Ongoing |
Z-1201-2025
|
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
|
Remel, Inc
|
Class II | Ongoing |
Z-1321-2025
|
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Descrip…
|
ZOLL Medical Corporation
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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-…
|
ZOLL Medical Corporation
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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-…
|
ZOLL Medical Corporation
|
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) …
|
ZOLL Medical Corporation
|
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-…
|
ZOLL Medical Corporation
|
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…
|
ZOLL Medical Corporation
|
Class II | Ongoing |
Z-1369-2025
|
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1366-2025
|
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1428-2025
|
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1430-2025
|
namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1329-2025
|
Z1 Femoral Hip System, Product Number 611777612
|
Zimmer, Inc.
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1439-2025
|
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNE…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1463-2025
|
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1445-2025
|
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1464-2025
|
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack N…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1441-2025
|
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Numb…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1443-2025
|
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1435-2025
|
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1447-2025
|
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1446-2025
|
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1452-2025
|
Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Numbe…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-1389-2025
|
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffu…
|
Immuno-Mycologics, Inc
|
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
|
Brainlab AG
|
Class II | Ongoing |
Z-1307-2025
|
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in…
|
CardioFocus, Inc.
|
Class II | Ongoing |
Z-1358-2025
|
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1338-2025
|
LABOR & DELIVERY PACK, Model Nos LLLD19H
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1343-2025
|
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1295-2025
|
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-1357-2025
|
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1336-2025
|
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1354-2025
|
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1348-2025
|
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1339-2025
|
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1333-2025
|
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1350-2025
|
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1352-2025
|
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1346-2025
|
CYSTO , Model No SACY80R
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1332-2025
|
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1344-2025
|
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1362-2025
|
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1335-2025
|
CYSTO PACK , Model N. HKCY31A
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1341-2025
|
BORN ON ARRIVAL KIT , Model No LLBN11B
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1345-2025
|
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1340-2025
|
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1342-2025
|
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1356-2025
|
AV FISTULA , Model No UTAV77T
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-1361-2025
|
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
|
American Contract Systems Inc
|
Class II | Ongoing |
Z-2569-2025
|
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data proce…
|
Medical Information Technology, Inc.
|
Class II | Ongoing |
Z-1427-2025
|
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web…
|
St. Jude Medical
|
Class II | Ongoing |
Z-2323-2025
|
HemosIL LMW Heparin Controls; Part Number: 0020300200;
|
Instrumentation Laboratory
|
Class II | Ongoing |
Z-1240-2025
|
Brivo MR355, NMRI system
|
GE Healthcare (China) Co., Ltd.
|
Class II | Ongoing |
Z-1265-2025
|
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1312-2025
|
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R…
|
Aesculap Inc
|
Class II | Ongoing |
Z-1239-2025
|
SIGNA Creator, SIGNA Explorer, NMRI systems
|
GE Healthcare (China) Co., Ltd.
|
Class II | Ongoing |
Z-1259-2025
|
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1242-2025
|
SIGNA MR355, SIGNA MR360, NMRI system
|
GE Healthcare (China) Co., Ltd.
|
Class II | Ongoing |
Z-1308-2025
|
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ…
|
Aesculap Inc
|
Class II | Ongoing |
Z-1263-2025
|
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1255-2025
|
Paradigm REF: MMT-712 and MMT-715
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1309-2025
|
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann…
|
Aesculap Inc
|
Class II | Ongoing |
Z-1258-2025
|
MiniMed insulin pump, REF: 620G (MMT-1750)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1257-2025
|
Paradigm insulin pump, REF: MMT-754
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1260-2025
|
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1256-2025
|
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
|
Medtronic MiniMed, Inc.
|
Class II | Ongoing |
Z-1247-2025
|
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmw…
|
LEICA BIOSYSTEMS NUSSLOCH GMBH
|
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
|
Stryker Corporation
|
Class II | Ongoing |
Z-1238-2025
|
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral device…
|
Pentax of America Inc
|
Class II | Ongoing |
Z-1237-2025
|
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic …
|
Pentax of America Inc
|
Class II | Ongoing |
Z-1046-2025
|
Optima XR646 HD. X-Ray imaging system.
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-1043-2025
|
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-1045-2025
|
Discovery XR656 HD. X-Ray imaging system.
|
GE Medical Systems, LLC
|
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…
|
Hiossen Inc.
|
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…
|
Hiossen Inc.
|
Class II | Ongoing |
Z-1203-2025
|
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
|
Dexcom, Inc.
|
Class II | Ongoing |
Z-1202-2025
|
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
|
Dexcom, Inc.
|
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…
|
Hiossen Inc.
|
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…
|
Hiossen Inc.
|
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…
|
Hiossen Inc.
|
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…
|
Guangzhou Pluslife Biotech Co., Ltd.
|
Class II | Ongoing |
Z-1978-2025
|
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Versio…
|
Guangzhou Pluslife Biotech Co., Ltd.
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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 …
|
Tyber Medical
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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…
|
Tyber Medical
|
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 …
|
Tyber Medical
|
Class II | Ongoing |
Z-1163-2025
|
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic…
|
Microbiologics Inc
|
Class II | Ongoing |
Z-1164-2025
|
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagn…
|
Microbiologics Inc
|
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…
|
KCI USA, INC.
|
Class II | Ongoing |
Z-2463-2025
|
Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: P…
|
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…
|
KCI USA, INC.
|
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…
|
RAYSEARCH LABORATORIES AB
|
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.…
|
RAYSEARCH LABORATORIES AB
|
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…
|
RAYSEARCH LABORATORIES AB
|
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 …
|
RAYSEARCH LABORATORIES AB
|
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…
|
RAYSEARCH LABORATORIES AB
|
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…
|
RAYSEARCH LABORATORIES AB
|
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.…
|
RAYSEARCH LABORATORIES AB
|
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.…
|
RAYSEARCH LABORATORIES AB
|
Class II | Ongoing |
Z-1248-2025
|
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
|
TERRAGENE S.A.
|
Class II | Ongoing |
Z-1066-2025
|
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitor…
|
Draeger Medical Systems, Inc.
|
Class II | Ongoing |
Z-1087-2025
|
Azurion 3 M12 System Code: (1) 722063 (2) 722221
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-0183-2022
|
Ellume COVID-19 Home Test
|
ELLUME LTD
|
Class I | Ongoing |
Z-1091-2025
|
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1076-2025
|
Allura CV20 System Code: 722031
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1092-2025
|
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1080-2025
|
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1084-2025
|
AlluraXperFD20/10 System Code: (1) 722029
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1081-2025
|
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
|
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 …
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1083-2025
|
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1086-2025
|
AlluraXperFD20/15 System Code: (1) 722058
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1089-2025
|
Azurion 5 M12 System Code: (1) 722227 (2) 722231
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-1078-2025
|
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-1269-2025
|
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
|
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…
|
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…
|
Hologic, Inc.
|
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…
|
CareFusion 303, Inc.
|
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 …
|
CareFusion 303, Inc.
|
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…
|
CareFusion 303, Inc.
|
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
|
Zimmer, Inc.
|
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…
|
XTANT Medical Holdings, Inc
|
Class II | Ongoing |
Z-1114-2025
|
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP12525…
|
US Endodontics, LLC
|
Class II | Ongoing |
Z-1112-2025
|
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
|
Beckman Coulter Inc.
|
Class II | Ongoing |
Z-1179-2025
|
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
|
Hollister Incorporated
|
Class II | Ongoing |
Z-1180-2025
|
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
|
Hollister Incorporated
|
Class II | Ongoing |
Z-1178-2025
|
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
|
Hollister Incorporated
|
Class II | Ongoing |
Z-1030-2025
|
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1096-2025
|
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general so…
|
Ethicon, LLC
|
Class II | Ongoing |
Z-1034-2025
|
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1036-2025
|
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1011-2025
|
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1035-2025
|
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1098-2025
|
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
|
Ethicon, LLC
|
Class II | Ongoing |
Z-1025-2025
|
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1027-2025
|
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1018-2025
|
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalo…
|
Randox Laboratories, Limited | Class II | Ongoing |
Z-1028-2025
|
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1024-2025
|
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1017-2025
|
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catal…
|
Randox Laboratories, Limited | Class II | Ongoing |
Z-1009-2025
|
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-1055-2025
|
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
|
Karl Storz Endoscopy
|
Class II | Ongoing |
Z-1051-2025
|
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
|
Karl Storz Endoscopy
|
Class II | Ongoing |
Z-1052-2025
|
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
|
Karl Storz Endoscopy
|
Class II | Ongoing |
Z-1104-2025
|
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
|
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
|
Karl Storz Endoscopy
|
Class II | Ongoing |
Z-1062-2025
|
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
|
Karl Storz Endoscopy
|
Class II | Ongoing |
Z-1004-2025
|
BD PCR Cartridges used with MAX System. Model Number: 437519
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-1053-2025
|
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
|
Karl Storz Endoscopy
|
Class II | Ongoing |
Z-1006-2025
|
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certif…
|
Ortho-Clinical Diagnostics, INc.
|
Class II | Ongoing |
Z-1005-2025
|
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified…
|
Ortho-Clinical Diagnostics, INc.
|
Class II | Ongoing |
Z-1007-2025
|
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer…
|
Ortho-Clinical Diagnostics, INc.
|
Class II | Ongoing |
Z-1054-2025
|
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
|
Karl Storz Endoscopy
|
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…
|
Intuitive Surgical, Inc.
|
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…
|
Intuitive Surgical, Inc.
|
Class II | Ongoing |
Z-1056-2025
|
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
|
Karl Storz Endoscopy
|
Class II | Ongoing |
Z-0768-2025
|
Bodor P and C series laser cutting machines
|
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
|
Karl Storz Endoscopy
|
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
|
Encore Medical, LP
|
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…
|
Augustine Temperature Management, LLC
|
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…
|
Augustine Temperature Management, LLC
|
Class II | Ongoing |
Z-0977-2025
|
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides …
|
Integra LifeSciences Corp.
|
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…
|
Trinity Sterile, Inc.
|
Class II | Ongoing |
Z-1012-2025
|
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46…
|
Trinity Sterile, Inc.
|
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…
|
Trinity Sterile, Inc.
|
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…
|
Trinity Sterile, Inc.
|
Class II | Ongoing |
Z-0984-2025
|
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
|
Medtronic Perfusion Systems
|
Class II | Ongoing |
Z-0761-2025
|
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
|
Encore Medical, LP
|
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…
|
ev3 Inc
|
Class II | Ongoing |
Z-0918-2025
|
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile …
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-0902-2025
|
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 834338…
|
QUIDEL ORTHO
|
Class II | Ongoing |
Z-1022-2025
|
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 Th…
|
Medtronic Navigation, Inc.
|
Class II | Ongoing |
Z-0946-2025
|
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960;…
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
Class II | Ongoing |
Z-0931-2025
|
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; …
|
Sklar Instruments
|
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; …
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
Class II | Ongoing |
Z-0927-2025
|
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (trache…
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
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; …
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
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, …
|
Sklar Instruments
|
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-…
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
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;…
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
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; …
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
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
|
Sklar Instruments
|
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…
|
Sklar Instruments
|
Class II | Ongoing |
Z-0845-2025
|
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, …
|
Coloplast Manufacturing US, LLC
|
Class II | Ongoing |
Z-0958-2025
|
Change Healthcare Cardiology Hemo software
|
A L I Technologies Ltd | Class II | Ongoing |
Z-0961-2025
|
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
|
Accriva Diagnostics, Inc.
|
Class II | Ongoing |
Z-0957-2025
|
McKesson Cardiology Hemo software
|
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.
|
Moximed, Inc.
|
Class II | Ongoing |
Z-0119-2022
|
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical S…
|
Windstone Medical Packaging, Inc.
|
Class I | Ongoing |
Z-0955-2025
|
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, …
|
IsoTis OrthoBiologics, Inc.
|
Class II | Ongoing |
Z-0919-2025
|
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
|
IsoTis OrthoBiologics, Inc.
|
Class II | Ongoing |
Z-0803-2025
|
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int…
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-0983-2025
|
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Descript…
|
O&M HALYARD, INC.
|
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-…
|
Olympus Corporation of the Americas
|
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…
|
Olympus Corporation of the Americas
|
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…
|
Olympus Corporation of the Americas
|
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…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0770-2025
|
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
|
Angiodynamics, Inc.
|
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-…
|
Olympus Corporation of the Americas
|
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-…
|
Olympus Corporation of the Americas
|
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…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0994-2025
|
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Gri…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0966-2025
|
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
|
Adept Medical Ltd | Class II | Ongoing |
Z-0964-2025
|
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
|
Adept Medical Ltd | Class II | Ongoing |
Z-0969-2025
|
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
|
Adept Medical Ltd | Class II | Ongoing |
Z-0965-2025
|
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
|
Adept Medical Ltd | Class II | Ongoing |
Z-0967-2025
|
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
|
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…
|
Siemens Healthcare Diagnostics, Inc.
|
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…
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-0743-2025
|
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832…
|
3M Company - Health Care Business
|
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…
|
Siemens Healthcare Diagnostics, Inc.
|
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…
|
Siemens Healthcare Diagnostics, Inc.
|
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…
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-0778-2025
|
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0792-2025
|
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DY…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0793-2025
|
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0790-2025
|
See DocMan
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0791-2025
|
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
Medtronic Neuromodulation
|
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,…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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 …
|
Medtronic Neuromodulation
|
Class II | Ongoing |
Z-0777-2025
|
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0753-2025
|
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming …
|
Abbott Medical
|
Class II | Ongoing |
Z-0786-2025
|
Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0789-2025
|
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, R…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0781-2025
|
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0686-2025
|
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
|
Philips North America Llc
|
Class II | Ongoing |
Z-0776-2025
|
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0802-2025
|
VACUETTE SAFELINK, REF: 450210
|
Greiner Bio-One GmbH | Class II | Ongoing |
Z-0815-2025
|
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-0818-2025
|
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-1042-2025
|
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0583-2025
|
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
|
Philips North America Llc
|
Class II | Ongoing |
Z-0709-2025
|
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
|
Mint Medical GmbH | Class II | Ongoing |
Z-0710-2025
|
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
|
Mint Medical GmbH | Class II | Ongoing |
Z-0672-2025
|
BD Pyxis CII Safe ES, REF: 1116-00
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-0671-2025
|
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-0670-2025
|
BD Pyxis MedStation ES, REF: 323
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-1326-2025
|
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-0758-2025
|
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0767-2025
|
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-0808-2025
|
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
|
Aerin Medical, Inc.
|
Class II | Ongoing |
Z-0756-2025
|
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0757-2025
|
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0755-2025
|
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
|
MEDLINE INDUSTRIES, LP - Northfield
|
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. …
|
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)
|
Gauthier Biomedical, Inc.
|
Class II | Ongoing |
Z-1132-2025
|
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-1126-2025
|
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP …
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0910-2025
|
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SC…
|
Cardinal Health 200, LLC
|
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…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0914-2025
|
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numb…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0915-2025
|
Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog …
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-1128-2025
|
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog N…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0916-2025
|
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-1131-2025
|
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0908-2025
|
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number …
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0728-2025
|
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
|
O&M HALYARD, INC.
|
Class II | Ongoing |
Z-1133-2025
|
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Ca…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-1129-2025
|
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTO…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0725-2025
|
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0722-2025
|
SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0719-2025
|
DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0718-2025
|
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0652-2025
|
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment…
|
ICU Medical, Inc.
|
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 …
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
KCI USA, INC.
|
Class II | Ongoing |
Z-0537-2025
|
dS Breast 16ch 1.5T
|
Philips North America Llc
|
Class II | Ongoing |
Z-0544-2025
|
Mammotrak Interventional Coil 3.0T
|
Philips North America Llc
|
Class II | Ongoing |
Z-0541-2025
|
Mammotrak Diagnostic Coil 1.5T
|
Philips North America Llc
|
Class II | Ongoing |
Z-0597-2025
|
Atellica CI Analyzer. Catalog Numbers: 10947347.
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-0540-2025
|
dS Breast 7ch 3.0T
|
Philips North America Llc
|
Class II | Ongoing |
Z-0548-2025
|
ST SENSE Breast Dx Coil
|
Philips North America Llc
|
Class II | Ongoing |
Z-0545-2025
|
SENSE Breast Coil
|
Philips North America Llc
|
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…
|
Securitas Healthcare LLC
|
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…
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0674-2025
|
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
|
Cardinal Health 200, LLC
|
Class II | Ongoing |
Z-0589-2025
|
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-0591-2025
|
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-0590-2025
|
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-0593-2025
|
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
|
Becton Dickinson & Co.
|
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)
|
Cartiva, Inc
|
Class II | Ongoing |
Z-0584-2025
|
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-0586-2025
|
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-0596-2025
|
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
|
Becton Dickinson & Co.
|
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…
|
SEASPINE ORTHOPEDICS CORPORATION
|
Class II | Ongoing |
Z-0581-2025
|
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
|
Smith & Nephew Inc.
|
Class II | Ongoing |
Z-0530-2025
|
AMS Artificial Urinary Sphincter Control Pump
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0531-2025
|
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0519-2025
|
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-0517-2025
|
Discovery MR750w 3.0T, whole body magnetic resonance scanner
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-0518-2025
|
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
|
GE Medical Systems, LLC
|
Class II | Ongoing |
Z-2403-2021
|
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
|
Micro Therapeutics Inc,
|
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…
|
Noah Medical
|
Class II | Ongoing |
Z-0550-2025
|
GE Proteus XR/A radiographic system
|
GE Healthcare (China) Co., Ltd. | Class II | Ongoing |
Z-0355-2025
|
Lab Kit, SKU DYLAB1018; Component No. 503581
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0359-2025
|
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0354-2025
|
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0666-2025
|
MICRO-X Rover Mobile X-ray System, # MXU-RV19
|
Micro-X Ltd. | Class II | Ongoing |
Z-0356-2025
|
UA KIT, SKU DYKM1690A; Component No. 503581
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0358-2025
|
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 50…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0363-2025
|
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
|
Karl Storz Endoscopy
|
Class II | Ongoing |
Z-0599-2025
|
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in h…
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-1251-2025
|
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
|
HUMAN MED AG | Class II | Ongoing |
Z-0486-2025
|
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
|
Maquet Cardiovascular, LLC
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0511-2025
|
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0485-2025
|
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
|
Maquet Cardiovascular, LLC
|
Class II | Ongoing |
Z-0509-2025
|
MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
CORNEAT VISION, LTD.
|
Class II | Ongoing |
Z-0533-2025
|
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ9…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0534-2025
|
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0554-2025
|
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
|
Shimadzu Corp. Analytical & Measuring Instruments Div. | Class II | Ongoing |
Z-0632-2025
|
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0623-2025
|
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0624-2025
|
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0639-2025
|
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
|
MEDLINE INDUSTRIES, LP - Northfield
|
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; …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0636-2025
|
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0640-2025
|
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3)…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
The Metrix Company
|
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…
|
The Metrix Company
|
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 …
|
The Metrix Company
|
Class II | Ongoing |
Z-0637-2025
|
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
The Metrix Company
|
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 …
|
The Metrix Company
|
Class II | Ongoing |
Z-0634-2025
|
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN P…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0644-2025
|
MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0622-2025
|
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
The Metrix Company
|
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 …
|
The Metrix Company
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0626-2025
|
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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 …
|
The Metrix Company
|
Class II | Ongoing |
Z-0635-2025
|
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0638-2025
|
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0642-2025
|
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYN…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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, …
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
The Metrix Company
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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-…
|
Cook Incorporated
|
Class II | Ongoing |
Z-0921-2025
|
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
|
DRG International, Inc.
|
Class II | Ongoing |
Z-0365-2025
|
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appli…
|
Stryker Corporation
|
Class II | Ongoing |
Z-0369-2025
|
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgica…
|
Stryker Corporation
|
Class II | Ongoing |
Z-0476-2025
|
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
|
Hobbs Medical, Inc.
|
Class II | Ongoing |
Z-0367-2025
|
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a…
|
Stryker Corporation
|
Class II | Ongoing |
Z-0475-2025
|
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
|
Hobbs Medical, Inc.
|
Class II | Ongoing |
Z-0366-2025
|
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur…
|
Stryker Corporation
|
Class II | Ongoing |
Z-0472-2025
|
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
|
Hobbs Medical, Inc.
|
Class II | Ongoing |
Z-0349-2025
|
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0368-2025
|
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosu…
|
Stryker Corporation
|
Class II | Ongoing |
Z-0474-2025
|
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
|
Hobbs Medical, Inc.
|
Class II | Ongoing |
Z-0471-2025
|
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
|
Hobbs Medical, Inc.
|
Class II | Ongoing |
Z-0370-2025
|
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgi…
|
Stryker Corporation
|
Class II | Ongoing |
Z-0473-2025
|
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
|
Hobbs Medical, Inc.
|
Class II | Ongoing |
Z-0462-2025
|
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a…
|
Getinge Usa Sales Inc
|
Class II | Ongoing |
Z-0309-2025
|
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
|
DeRoyal Industries Inc
|
Class II | Ongoing |
Z-0308-2025
|
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
|
DeRoyal Industries Inc
|
Class II | Ongoing |
Z-0460-2025
|
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a…
|
Getinge Usa Sales Inc
|
Class II | Ongoing |
Z-0458-2025
|
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a…
|
Getinge Usa Sales Inc
|
Class II | Ongoing |
Z-0307-2025
|
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
|
DeRoyal Industries Inc
|
Class II | Ongoing |
Z-0318-2025
|
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2…
|
GE Healthcare
|
Class II | Ongoing |
Z-0463-2025
|
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a…
|
Getinge Usa Sales Inc
|
Class II | Ongoing |
Z-0619-2025
|
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 …
|
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…
|
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…
|
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)
|
Siemens Healthcare Diagnostics, Inc.
|
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 …
|
Bard Peripheral Vascular Inc
|
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…
|
King Systems Corp. dba Ambu, Inc.
|
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. …
|
King Systems Corp. dba Ambu, Inc.
|
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…
|
King Systems Corp. dba Ambu, Inc.
|
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 …
|
King Systems Corp. dba Ambu, Inc.
|
Class II | Ongoing |
Z-0286-2025
|
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
|
Siemens Healthcare Diagnostics Inc
|
Class II | Ongoing |
Z-0808-2019
|
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number …
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
Class I | Ongoing |
Z-2055-2020
|
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
|
Heartware, Inc.
|
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…
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-1544-2021
|
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
|
Infusion Pump Repair
|
Class I | Ongoing |
Z-1336-2021
|
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN,…
|
Heartware, Inc.
|
Class I | Ongoing |
Z-1340-2021
|
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2909-2020
|
Alaris System PC Unit Model 8015
|
CareFusion 303, Inc.
|
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…
|
Medtronic Inc.
|
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…
|
Medtronic Inc.
|
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…
|
Maquet Datascope Corp - Cardiac Assist Division
|
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…
|
CareFusion 303, Inc.
|
Class I | Ongoing |
Z-1339-2021
|
Medtronic HVAD Monitor Data Cable, Product Number: 1575
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2058-2020
|
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2056-2020
|
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2020-2021
|
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1726-2015
|
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intende…
|
HeartWare Inc
|
Class I | Ongoing |
Z-1427-2020
|
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients wit…
|
Heartware, Inc.
|
Class I | Ongoing |
Z-0807-2019
|
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) …
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
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…
|
Heartware
|
Class I | Ongoing |
Z-0812-2019
|
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1…
|
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
|
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.…
|
HeartWare Inc
|
Class I | Ongoing |
Z-1428-2020
|
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in pa…
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2057-2020
|
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
|
Heartware, Inc.
|
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…
|
Medtronic Inc.
|
Class I | Ongoing |
Z-1337-2021
|
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT…
|
Heartware, Inc.
|
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…
|
The Biomed Guys
|
Class I | Ongoing |
Z-1338-2021
|
Medtronic HVAD Alarm Adapter, Product Number: 1450
|
Heartware, Inc.
|
Class I | Ongoing |
Z-2019-2021
|
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
|
Boston Scientific Corporation
|
Class I | Ongoing |
Z-1341-2021
|
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1…
|
Heartware, Inc.
|
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 …
|
Boston Scientific Corporation
|
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…
|
Medtronic Inc.
|
Class I | Ongoing |
Z-0391-2025
|
Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0413-2025
|
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0392-2025
|
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0385-2025
|
Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0390-2025
|
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0454-2025
|
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0394-2025
|
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0433-2025
|
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0427-2025
|
Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15
|
AVID Medical, Inc.
|
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 …
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0387-2025
|
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0448-2025
|
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
|
AVID Medical, Inc.
|
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 …
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0420-2025
|
Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0402-2025
|
Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0401-2025
|
Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0438-2025
|
Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0383-2025
|
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0431-2025
|
Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0407-2025
|
Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0444-2025
|
Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
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…
|
Integra LifeSciences Corp.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0384-2025
|
Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0422-2025
|
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0428-2025
|
Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0408-2025
|
Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0421-2025
|
Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0449-2025
|
Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0393-2025
|
Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0412-2025
|
Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0443-2025
|
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0426-2025
|
Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0455-2025
|
Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0409-2025
|
Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0414-2025
|
Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0395-2025
|
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0419-2025
|
Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0400-2025
|
Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0452-2025
|
Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0416-2025
|
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0453-2025
|
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0430-2025
|
Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15
|
AVID Medical, Inc.
|
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…
|
Integra LifeSciences Corp.
|
Class II | Ongoing |
Z-0410-2025
|
Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0388-2025
|
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
|
AVID Medical, Inc.
|
Class II | Ongoing |
Z-0386-2025
|
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
|
AVID Medical, Inc.
|
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-…
|
Covidien LP
|
Class II | Ongoing |
Z-0228-2025
|
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7…
|
Baxter Healthcare Corporation
|
Class II | Ongoing |
Z-0498-2025
|
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Numbe…
|
Olympus Corporation of the Americas
|
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…
|
Topcon Medical Systems, Inc.
|
Class II | Ongoing |
Z-0285-2025
|
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo…
|
Zimmer, Inc.
|
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…
|
Ambu Inc.
|
Class II | Ongoing |
Z-0596-2024
|
Regard Dressing change kit, Item Number 800026006
|
ROi CPS LLC
|
Class I | Terminated |
Z-0351-2025
|
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Produ…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0054-2025
|
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) …
|
Integra LifeSciences Corp.
|
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…
|
Abbott Molecular, Inc.
|
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 …
|
Abbott Molecular, Inc.
|
Class II | Ongoing |
Z-0137-2025
|
SynchroMed II Infusion Pump. Product Number: 8637-20
|
Medtronic Neuromodulation
|
Class II | Ongoing |
Z-0364-2025
|
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-3245-2024
|
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
|
Waldemar Link GmbH & Co. KG (Corp. Hq.) | Class II | Ongoing |
Z-0024-2025
|
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
|
Atrium Medical Corporation
|
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…
|
Enchroma Inc
|
Class II | Ongoing |
Z-0055-2025
|
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical…
|
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…
|
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
|
Class II | Ongoing |
Z-0105-2025
|
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes a…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0265-2025
|
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The …
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-0096-2025
|
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an …
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0043-2025
|
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
|
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 …
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0109-2025
|
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive dis…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0097-2025
|
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an int…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0104-2025
|
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interacti…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0101-2025
|
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes a…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0112-2025
|
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an …
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-0264-2025
|
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0088-2025
|
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 149…
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0165-2025
|
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, RE…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0167-2025
|
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0371-2025
|
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur…
|
Bard Peripheral Vascular Inc
|
Class II | Ongoing |
Z-0159-2025
|
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0151-2025
|
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0180-2025
|
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0085-2025
|
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
|
LEICA BIOSYSTEMS NUSSLOCH GMBH | Class II | Ongoing |
Z-0172-2025
|
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0179-2025
|
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0178-2025
|
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ223…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0153-2025
|
Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK …
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0163-2025
|
Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0149-2025
|
Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0023-2025
|
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications dur…
|
Howmedica Osteonics Corp.
|
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…
|
B-K Medical A/S
|
Class II | Ongoing |
Z-0162-2025
|
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0087-2025
|
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501,…
|
LEICA BIOSYSTEMS NUSSLOCH GMBH | Class II | Ongoing |
Z-0170-2025
|
Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0090-2025
|
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 1…
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0086-2025
|
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sect…
|
LEICA BIOSYSTEMS NUSSLOCH GMBH | Class II | Ongoing |
Z-0148-2025
|
Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0089-2025
|
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 149…
|
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…
|
MEDLINE INDUSTRIES, LP - Northfield
|
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…
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
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 …
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
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…
|
Philips North America Llc
|
Class II | Ongoing |
Z-0062-2025
|
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M…
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-0061-2025
|
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF…
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-0034-2025
|
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0057-2025
|
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3…
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-0033-2025
|
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0060-2025
|
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto…
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-3155-2024
|
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the s…
|
Tornier, Inc
|
Class II | Ongoing |
Z-3311-2024
|
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia w…
|
CooperVision, Inc.
|
Class II | Ongoing |
Z-3209-2024
|
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic…
|
Microcare Medical
|
Class II | Ongoing |
Z-3310-2024
|
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with asti…
|
CooperVision, Inc.
|
Class II | Ongoing |
Z-3309-2024
|
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
|
Tornier, Inc
|
Class II | Ongoing |
Z-0123-2025
|
MEDLINE KIT CV I II, REF DYNJ906071B
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0122-2025
|
MEDLINE OPEN HEART, REF DYNJ904261B
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0121-2025
|
MEDLINE OPEN HEART PACK, REF DYNJ66216C
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0053-2025
|
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0119-2025
|
MEDLINE HEART CABG CDS, REF CDS983376R
|
MEDLINE INDUSTRIES, LP - Northfield
|
Class II | Ongoing |
Z-0094-2025
|
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatio…
|
Beckman Coulter, Inc.
|
Class II | Ongoing |
Z-3182-2024
|
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
|
Safeguard US Operating LLC
|
Class II | Ongoing |
Z-3181-2024
|
HAWK Warming Grid, Item Number: 59-300
|
Safeguard US Operating LLC
|
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…
|
Safeguard US Operating LLC
|
Class II | Ongoing |
Z-0131-2025
|
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: …
|
Nova Ortho-Med Inc
|
Class II | Ongoing |
Z-0129-2025
|
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description:…
|
Nova Ortho-Med Inc
|
Class II | Ongoing |
Z-3210-2024
|
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbod…
|
Stryker Spine
|
Class II | Ongoing |
Z-0229-2025
|
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
|
Olympus Corporation of the Americas
|
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…
|
Medtronic Navigation, Inc.
|
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…
|
Healgen Scientific Llc
|
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…
|
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…
|
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
|
Intuitive Surgical, Inc.
|
Class II | Ongoing |
Z-0181-2025
|
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0127-2025
|
Horizon Cardiology Hemo. Version 12.2.
|
CHANGE HEALTHCARE CANADA COMPANY | Class II | Ongoing |
Z-3305-2024
|
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-3184-2024
|
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
|
Cypress Medical Products LLC
|
Class II | Ongoing |
Z-0072-2025
|
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
|
Merit Medical Systems, Inc.
|
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…
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-0071-2025
|
basixSKY Inflation Device, REF: SKY1802
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-0069-2025
|
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-0066-2025
|
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-0064-2025
|
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
|
Merit Medical Systems, Inc.
|
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…
|
Windstone Medical Packaging, Inc.
|
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…
|
Windstone Medical Packaging, Inc.
|
Class II | Ongoing |
Z-0027-2025
|
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in …
|
Windstone Medical Packaging, Inc.
|
Class II | Ongoing |
Z-0031-2025
|
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in …
|
Windstone Medical Packaging, Inc.
|
Class II | Ongoing |
Z-0028-2025
|
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged …
|
Windstone Medical Packaging, Inc.
|
Class II | Ongoing |
Z-3140-2024
|
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
|
CareFusion 303, Inc.
|
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…
|
B Braun Medical Inc
|
Class II | Ongoing |
Z-3142-2024
|
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
|
CareFusion 303, Inc.
|
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…
|
B Braun Medical Inc
|
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…
|
B Braun Medical Inc
|
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…
|
B Braun Medical Inc
|
Class II | Ongoing |
Z-3177-2024
|
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model…
|
B Braun Medical Inc
|
Class II | Ongoing |
Z-3139-2024
|
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
|
CareFusion 303, Inc.
|
Class II | Ongoing |
Z-3138-2024
|
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
|
CareFusion 303, Inc.
|
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…
|
Siemens Healthcare Diagnostics, Inc.
|
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…
|
Innovasis, Inc
|
Class II | Ongoing |
Z-0134-2025
|
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v…
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-3191-2024
|
Custom Procedure Kit, REF: K12T-11077
|
Merit Medical Systems, Inc.
|
Class II | Ongoing |
Z-3097-2024
|
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. …
|
Smith & Nephew Inc.
|
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…
|
SEER MEDICAL PTY LTD | Class II | Ongoing |
Z-1292-2025
|
Vios Monitoring System Bedside Monitor Model BSM2050
|
Murata Vios, Inc.
|
Class II | Ongoing |
Z-0142-2025
|
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril…
|
Physio-Control, Inc.
|
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…
|
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…
|
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, …
|
GE Healthcare GmbH | Class II | Ongoing |
Z-3244-2024
|
Pacemaker, COPM11B; Medical convenience kit
|
American Contract Systems, Inc.
|
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…
|
Cook Biotech, Inc.
|
Class II | Ongoing |
Z-3237-2024
|
Hand Pack, AKHD97C; Medical convenience kit
|
American Contract Systems, Inc.
|
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…
|
Cook Biotech, Inc.
|
Class II | Ongoing |
Z-3238-2024
|
Vaginal Delivery, ASDV25B; Medical convenience kit
|
American Contract Systems, Inc.
|
Class II | Ongoing |
Z-0044-2025
|
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
|
Howmedica Osteonics Corp.
|
Class II | Ongoing |
Z-3235-2024
|
IR Procedure Pack, CEAT19W; Medical convenience kit
|
American Contract Systems, Inc.
|
Class II | Ongoing |
Z-3242-2024
|
Nasal Sinus Pack, MTSN26B; Medical convenience kit
|
American Contract Systems, Inc.
|
Class II | Ongoing |
Z-3226-2024
|
PACEMAKER PACK, SLCV01J; Medical convenience kit
|
American Contract Systems, Inc.
|
Class II | Ongoing |
Z-3236-2024
|
Neuro Vascular, ANKV91A; Medical convenience kit
|
American Contract Systems, Inc.
|
Class II | Ongoing |
Z-3233-2024
|
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
|
American Contract Systems, Inc.
|
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…
|
Cook Biotech, Inc.
|
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 …
|
Cook Biotech, Inc.
|
Class II | Ongoing |
Z-3234-2024
|
Paracentesis Thoracente, SLPT76H; Medical convenience kit
|
American Contract Systems, Inc.
|
Class II | Ongoing |
Z-3239-2024
|
Cath Lab Pack, CECL02P; Medical convenience kit
|
American Contract Systems, Inc.
|
Class II | Ongoing |
Z-3227-2024
|
Endovascular AAA Pack, ESED52B; Medical convenience kit
|
American Contract Systems, Inc.
|
Class II | Ongoing |
Z-3122-2024
|
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
|
BioFire Diagnostics, LLC
|
Class II | Ongoing |
Z-3232-2024
|
Shoulder, SESH18I; Medical convenience kit
|
American Contract Systems, Inc.
|
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…
|
Cook Biotech, Inc.
|
Class II | Ongoing |
Z-3243-2024
|
Cysto, FTCY03L; Medical convenience kit
|
American Contract Systems, Inc.
|
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…
|
Cook Biotech, Inc.
|
Class II | Ongoing |
Z-2953-2024
|
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number…
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | Ongoing |
Z-2967-2024
|
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-2957-2024
|
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-2966-2024
|
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-2964-2024
|
Pump 381 Pump Set (US); Product Code: 1000080;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-2961-2024
|
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-2960-2024
|
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-2969-2024
|
Impella CP Smart Assist Set; Product Code: 1000402;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-2970-2024
|
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-2965-2024
|
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
|
Abiomed, Inc.
|
Class II | Ongoing |
Z-1995-2026
|
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
|
Straumann USA LLC
|
Class II | Ongoing |
Z-1994-2026
|
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutmen…
|
Straumann USA LLC
|
Class II | Ongoing |
Z-0051-2025
|
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M…
|
AURIS HEALTH INC
|
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…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3279-2024
|
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3277-2024
|
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intende…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3246-2024
|
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of …
|
Becton Dickinson & Co.
|
Class II | Ongoing |
Z-3280-2024
|
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3265-2024
|
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3270-2024
|
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3268-2024
|
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3266-2024
|
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intend…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3247-2024
|
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically s…
|
Becton Dickinson & Co.
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3267-2024
|
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intend…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1937-2026
|
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install…
|
Foundation Medicine, Inc.
|
Class II | Ongoing |
Z-3278-2024
|
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3276-2024
|
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System …
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-3275-2024
|
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System I…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
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…
|
Boston Scientific Corporation
|
Class II | Ongoing |
Z-1854-2026
|
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-0040-2025
|
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
|
Inspire Medical Systems Inc.
|
Class II | Ongoing |
Z-1851-2026
|
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-3189-2024
|
Stainless Steel Sims Uterine Sound, Part Number 64-601
|
CooperSurgical, Inc.
|
Class II | Ongoing |
Z-1853-2026
|
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
|
Olympus Corporation of the Americas
|
Class II | Ongoing |
Z-3065-2024
|
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-3063-2024
|
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-2738-2024
|
DR 800. Digital Radiography X-ray System.
|
Agfa N.V. | Class II | Ongoing |
Z-3064-2024
|
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-2008-2026
|
Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2037-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Nu…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2012-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2014-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2030-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2035-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medlin…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2023-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medlin…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2022-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline …
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2011-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2029-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2027-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, AC…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2038-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2034-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medli…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2009-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Num…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2006-2026
|
Brand Name: Leksell Vantage Arc System REF: 1053958
|
Elekta, Inc.
|
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…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2016-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medli…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2026-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2013-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit numb…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2020-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medli…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2018-2026
|
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT,…
|
Medline Industries, LP
|
Class II | Ongoing |
Z-2844-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2909-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2890-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2937-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2931-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2781-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
|
Beaver Visitec International, Inc.
|
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…
|
Siemens Healthcare Diagnostics, Inc.
|
Class II | Ongoing |
Z-2896-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2888-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2877-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001503;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2928-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2875-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2843-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2860-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2892-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2876-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001501;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2913-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001775;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2847-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2852-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001200;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2800-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000192;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2906-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001712;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2887-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2891-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001622;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2822-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000759;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2924-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2911-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2893-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001629;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |
Z-2886-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;
|
Beaver Visitec International, Inc.
|
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 …
|
ARROW INTERNATIONAL Inc.
|
Class II | Ongoing |
Z-2927-2024
|
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943;
|
Beaver Visitec International, Inc.
|
Class II | Ongoing |