BEUDAMED
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    Pastelle Pro

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

    AARHUS ANCHORAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSYS HIP SYSTEM FEMORAL STEM CEMENTED COLLARED

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWY·November 21, 2008

    RINGLOC + HI-WALL TRIAL LINER 3/8" SCREW SIZE 25 X 44MM I.D.

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code IQO·September 9, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·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