BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    PATIENT MOVER(TM)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517385901·PRECEPT Screw Shank, 10.5x55mm Modular

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809916497810·Long-arm Multi-Axial Fenestrated Screw, Ø10.5 x...

    PowerX Lipo System

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

    PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNIFY CRT-D

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

    30 INCH TRANSPORT

    FDA Adverse Event
    Malfunction ·STRYKER CORP. MEDICAL DIV.·Product code FPO·October 29, 2010

    ATLAS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·October 31, 2012

    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