38 results
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7ms
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Sources: EU EUDAMED, US FDA
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Enforcement
Class I
·Ongoing·HeartWare, Inc·October 19, 2016
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
FDA Enforcement
Class I
·Ongoing·Heartware·May 3, 2017
Extended Tip Applicator 8CM, Box of 1.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025
Extended Tip Applicator, 8CM, Box of 5.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025
Extended Tip Applicator, 15 CM, Box of 5.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.
FDA Enforcement
Class I
·Ongoing·Heartware·June 6, 2018
IDM-MICRO-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-ARLITE-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-MULTI-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Multi Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
FDA Enforcement
Class I
·Ongoing·Fresenius Kabi USA, LLC·June 18, 2025
All-round Joystick R-net Light. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp.·August 3, 2022
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp.·December 20, 2023
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024