BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    WVSM (Wireless Vital Signs Monitor) RWC + miniCap

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bernafon

    FDA UDI
    Bernafon AG·05711584087091·ZR3, KIT 10 85 BE ZERENA 3

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111442292·STILLE-BARRAYA FORCEPS 3X4 8 INCHES

    CORONIS FUSION 4MP DL

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERFADEX AND PERFADEX WITH THAM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·August 4, 2011

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·November 1, 2013

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012