BEUDAMED
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    SofWave System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LCP

    FDA UDI
    Synthes GmbH·10886982167514·2.4MM LCP® RADIAL HEAD RIM PLATE 4 HOLES-LEFT

    ACON MULTI-CLIN DRUG SCREEN TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CROC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLUM XL3M PUMP

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·November 19, 2008

    UNIVERSAL DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·September 2, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·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