BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    MDx-Chex for BCY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Evolution Spine Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    uDR Aurora CX

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZOOM LATITUDE PROGRAMMER

    FDA Adverse Event
    Malfunction ·EXTERNAL MANUFACTURER·Product code LWS·November 11, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 19, 2011

    LIMA HIP INSTRUMENT

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JDI·July 25, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014