BEUDAMED
    63 results · 28ms · Sources: EU EUDAMED, US FDA

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    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 HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    FDA Enforcement
    Class I ·Ongoing·Heartware, Inc.·March 18, 2020

    HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

    FDA Enforcement
    Class I ·Ongoing·HeartWare Inc·June 24, 2015