BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    MICRO-HEMATOCRIT CENTRIFUGE 335/336

    FDA 510(k)
    FDA Class 2 ·Hematology

    PTS PANELS LIPID PANEL TEST STRIPS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CUVIS-spine

    FDA 510(k)
    FDA Class 2 ·Neurology

    CATGUT CHROM 1 (5) 90CM HR37S

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAM·February 28, 2014

    DIRECT DRIVE LCA

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GDO·August 27, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS INC.·Product code DYB·September 10, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    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