BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUTE AND CHRONIC CATHETER REPAIR KIT

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

    O.R. DRAPES

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

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 24, 2014

    LGN CR HIGH FLEX XLPE SZ 3-4 9MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·January 2, 2013

    CURVED POSITIONER/IMPACTOR HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·November 3, 2010

    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