BEUDAMED
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    Diode Laser Therapy Device (DF-DIODE LASER-S1)

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

    B&J DVT Foot Garments, Models 820 Series

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WINGMAN EXTENDABLE TIP SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIVONA TTS TRACHESTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC·Product code JOH·August 11, 2011

    9710055-2008-00010

    FDA Adverse Event
    Other ·Product code FSY·September 5, 2008

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·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