BEUDAMED
    1,461 results · 50ms · 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.

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·July 12, 2006

    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

    FDA Recall
    Terminated ·SynCardia Systems Inc.·Product code LOZ·August 6, 2015

    SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·December 4, 2020

    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

    FDA Enforcement
    Class I ·Terminated·SynCardia Systems Inc.·September 23, 2015

    SYNCARDIA FREEDOM DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·July 1, 2015

    SYNCARDIA COMPANION 2 DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·August 11, 2015

    SYNCARDIA FREEDOM DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·July 20, 2015

    SYNCARDIA FREEDOM ONBOARD BATTERY

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·July 24, 2015

    SYNCARDIA COMPANION 2 DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·September 28, 2015