BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Immunology

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464058181·OTICON ZIRCON 1 MINIRITE T C092

    COROENT XL-F SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MED - NEUROMODULATION·Product code GZB·October 30, 2014

    ISOFLEX LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 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