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

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    BIOTROL URINE PROTEINS REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS , INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 28, 2010

    CURRENT PLUS VR, DF-4 CONNECTOR

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

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 31, 2012

    OEC UroView 2800, fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 31, 2016

    OEC 9800, fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 31, 2016

    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