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

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    RIA-GNOST FERRITIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)

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

    MODIFICATION TO: GIRAFFE AND PANDA WARMER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 24, 2014

    UNIVERSAL DRIVER SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHPAEDICS MAHWAH·Product code LXH·November 1, 2010

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·December 26, 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