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

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    360D DC DEFIBRILLATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228740911·GC Initial™ Ti Fluo-Dentin FD-91, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704230·GC Initial™ AL Inside IN-43 Sun, 20g

    SILCATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ABBOTT LIFECARE 900 VOLUMETRIC PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·May 29, 2014

    UNK PRODUCT - RIGHT KNEE

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code KRO·October 14, 2010

    2031527-2012-00112

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·December 14, 2012

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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