BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    MASK, OXYGEN

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704247·GC Initial™ AL Inside IN-44 Sand, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228740921·GC Initial™ Ti Fluo-Dentin FD-92, 20g

    MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DIAGNOSTIC MICROSOPCE SLIDES

    FDA 510(k)

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

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

    VENTAK PRIZM

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 19, 2010

    LIBERTÉ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·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