BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    AXIOM FEMORAL VENUS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIODERM SCIENCES WOUND HEALING SPRAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·May 31, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MPRI·Product code DTB·November 21, 2012

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTL·August 24, 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