BEUDAMED
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    Invictus® Small Stature Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: ON-BOARD IMAGER DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROFEMUR® GLADIATOR® Cemented Classic Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·November 21, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 10, 2011

    LCP-DF 4.5/5 R 9HO L236 SST

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·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