BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    COMPRES PORTABLE HEAT PADS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PreView™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788210460·Variable Angle Screw Guide – Cervical

    STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    COBRA COOLED SURGICAL PROBE, MODEL 1596X

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

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    JAGWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·November 6, 2012

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·August 31, 2010

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 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