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

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    CERVICAL COLLAR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SMARTSTEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE

    FDA 510(k)
    FDA Unclassified ·Unknown

    EXPEDIUM SI POLYAXL SCREW 6 X 45MM

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

    75MM SELECTABLE NEW TLC

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 7, 2012

    INFUSOR TWO DAY 2ML/HR 12 PK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2010

    PROG VALVE INLINE W SG

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·September 12, 2025

    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