BEUDAMED
    8 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.

    FIXED-SIZE UTERINE DILATOR

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077823·CUP CURETTE UP #1 - SERRATED

    UroLift System UL400

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

    SINUS QUICK EB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·December 29, 2012

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·November 3, 2010

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    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