BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517385673·PRECEPT Screw Shank, 10.5x40mm Modular

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809916497780·Long-arm Multi-Axial Fenestrated Screw, Ø10.5 x...

    RIA TEST KIT, CENTRIA DIGOXIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Ponto 4

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SECURE 3 MED/SURG BED

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

    FORTIFY ASSURA DR

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

    ON-Q SILVER SOAKER CATHETER

    FDA Adverse Event
    Injury ·I-FLOW LLC·Product code BSO·December 14, 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