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

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    xR IVD

    FDA 510(k)
    FDA Class 2 ·Pathology

    VALUPEN,PROFILE

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

    TRIA FANP

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

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    OMNIDIAGNOST

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code JAA·September 25, 2008

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 22, 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