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

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    Pivot Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Surgical face mask (Model: Flat Ear Loop/CN102)

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

    NobelProcera HT ML Full Contour Zirconia Crown

    FDA 510(k)
    FDA Class 2 ·Dental

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 15, 2014

    FLEXIBLE FULGURATING ELECTRODE

    FDA Adverse Event
    Other ·GYRUS ACMI, INC.·Product code FBO·August 25, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 30, 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