BEUDAMED
    73 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    FDA Enforcement
    Class II ·Terminated·Heartware Inc·May 22, 2013

    STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    HeartWare HVAD Pump Kit, REF 1103

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF 1104JP

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare Model 1102

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF MCS1705PU

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare Model 1100

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF 1104CA-CLIN

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare Model 1101

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF 1104

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF 1205

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used 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 is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.

    FDA Enforcement
    Class I ·Terminated·Heartware, Inc.·July 20, 2016