BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    RUBELLA ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Parcus Synd-EZ Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM

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

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·April 18, 2018

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 24, 2014

    SOFPORT ADVANCED OPTICS ASPHERIC LENS

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·October 25, 2010

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 28, 2012

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 12, 2013

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 12, 2013

    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