16 results
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11ms
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Sources: EU EUDAMED, US FDA
Cub 2 Enclosed Bed Canopy System
FDA Enforcement
Class I
·Ongoing·Sensory Medical Inc·April 20, 2022
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 Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
FDA Enforcement
Class I
·Ongoing·Heartware·May 3, 2017
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
FDA Enforcement
Class I
·Ongoing·Navajo Manufacturing Company·April 1, 2026
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
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
FDA Enforcement
Class I
·Ongoing·Vyaire Medical·March 6, 2024
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
FDA Enforcement
Class I
·Ongoing·Maquet Medical Systems USA·December 13, 2023
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
FDA Enforcement
Class I
·Ongoing·Ventec Life Systems, Inc.·May 13, 2026
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