BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    TRACHEOSTOMY CLEANING TRAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·May 30, 2014

    UV FLASH TRANSFER SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 20, 2012

    HEARTSTRING III PROXIMAL SEAL 4.3 MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·September 17, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017