BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NA

    FDA UDI
    STERILMED, INC.·10888551007542·SAW BLADE SAGITTAL K9 K2000 SERIES

    TECHNICON HDL CHOLESTEROL METHOD

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OSW Aligner System

    FDA 510(k)
    FDA Class 2 ·Dental

    TECNIS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·June 24, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·January 1, 2013

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXO·November 6, 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