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

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    EVE Synergy (EVE-20M)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Facet 28G Universal Lancet

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

    BRIGHT GOLD XH

    FDA 510(k)
    FDA Class 2 ·Dental

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011

    AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code MEQ·November 10, 2014

    M2A 38MM MODULAR HEAD STD NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·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