BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Lunar Astra

    FDA 510(k)
    FDA Class 2 ·Radiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694018524·MFx 2.7mm x 18mm Angulated Locking Safety Screw

    V40 BIOLOX DELTA CERAMIC FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Qmenta Care Platform Family

    FDA 510(k)
    FDA Class 2 ·Radiology

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 13, 2014

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    ZEPHYR XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·July 29, 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