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

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    FAQ™ (LED Panel); FAQ™ (Dual LED Panel)

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

    Trak Male Fertility Testing System

    FDA 510(k)
    FDA Class 2 ·Hematology

    CarboClear Lumbar Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISCOVERY DR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·November 11, 2008

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 10, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 17, 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