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

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    PATIENT EXAMINATION GLOVES (VINYL)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VENOJECT AUTOSEP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PK DISSECTING FORCEPS INSTRUMENT

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

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 2, 2013

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 8, 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