BEUDAMED
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    Logical Liner; World Liner; World Knee Patella

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LCP

    FDA UDI
    Synthes GmbH·10886982167521·2.4MM LCP® RADIAL HEAD NECK PLATE 2 HOLES

    JUSHA-M33C LCD MONITOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONARCH NASAL IMPLANT

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

    LIGHTSPEED RT 16 SCANNER

    FDA Adverse Event
    GE MEDICAL SYSTEMS, LLC·Product code JAK·October 31, 2008

    VM8: MICROSTREAM CO2

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MHX·September 2, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·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