BEUDAMED
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    Arisure® Closed Male Luer with Spike Adapter (YM060)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464058495·HEARLINK 3030 MNR T BL/DG

    KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AXSYM CYCLOSPORINE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 10, 2014

    BARD AVAULTA VAGINAL MESH

    FDA Adverse Event
    Injury ·BARD AVAULTA·Product code FTL·September 2, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·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