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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    UNIVERSAL BUCKS TRACTION

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    NEUROPACE BURR HOLE COVER MODEL 8110

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EXPEDIUM SI POLYAXL SCREW 6 X 45MM

    FDA Adverse Event
    Injury ·DEPUY SYNTHES SPINE·Product code NKB·May 21, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·November 7, 2012

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MMI·September 1, 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