BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    HERPES TRANSETTE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PRECISE SHP DIODE LASER

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

    MEDS-3 NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 26, 2014

    UNKNOWN DEPUY ACS GR2 32MM POLY LINER

    FDA Adverse Event
    Injury ·Product code JDI·November 8, 2012

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·September 2, 2010

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 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