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

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    ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Partial Pelvis Replacement

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575048588·5 hole flanges

    AQUILION RXL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Diamond Air+ (UI04A, UI04B, UI04C)

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

    POWERLINK SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·May 20, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 6, 2012

    VISTEC SPG 4X8 STR 10 X 12 PLY

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GDY·August 26, 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