BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays

    FDA 510(k)
    FDA Class 2 ·Neurology

    VIBRANCE KEGEL DEVICE (VKD)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INTRALASE FS LASER

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

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75 CM NON US

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·November 18, 2008

    COLLEAGUE

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

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·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