BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    Rod Registration Frame

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSTEOSORB TACK FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Reliance Endoscope Processing System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    EAGLE PLUS SCREW REMOVAL TOOL INNER SHAFT

    FDA Adverse Event
    Malfunction ·DEPUY SPINE, INC.·Product code LXH·October 28, 2008

    RF MULTIGEN

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GXD·July 19, 2011

    1.8MM TI LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWP·July 17, 2013

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·May 29, 2024

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·October 23, 2024

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·March 12, 2024

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    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