BEUDAMED
    12 results · 17ms · Sources: EU EUDAMED, US FDA

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    TOTAL BILIRUBIN FOR CONTINUOUS FLOW

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Halo Buttress Plate

    FDA UDI
    Nuvasive, Inc.·00887517728012·ALIF Buttress Plate, 25mm

    Zavation

    FDA UDI
    Zavation LLC·00197157004040·Modular Screwdriver Lock

    ZAVATION ROD TEMPLATE

    FDA UDI
    Zavation LLC·00197157014766·TIGER 2 ROD TEMPLATE 200

    CHROMID VRE AGAR, MODEL: REF 43 851

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DRX-Revolution Mobile X-ray System

    FDA 510(k)
    FDA Class 2 ·Radiology

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024140721·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024140738·

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code HWC·June 24, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 29, 2010

    LINIX SMART SD 65/18

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO KG·Product code LWS·November 15, 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