BEUDAMED
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    OSTEOPAL® V

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    MBT TRAY SLEEVE POR M/L 45MM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code NJL·January 10, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 19, 2008

    HUDSON HVT ET TUBE 7.0 MM

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code BTR·August 19, 2011

    OBTRYX SYSTEM

    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