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

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    MODEL 200 SQUID

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NOVEL FIT AND FILL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOTACK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOGIC TIBIA PS MOD INSRT SZ 2 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 28, 2024

    BRAUN

    FDA Adverse Event
    Malfunction ·BBRAUN MEDICAL·Product code FPA·May 19, 2014

    COOK 4 FRENCH 130 CM

    FDA Adverse Event
    Malfunction ·COOK MEDICAL·Product code GCB·October 31, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code MDS·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