BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    FINGER FLEXION SPLINT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIZION + DR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DENTSPLY PROFESSIONAL·Product code EKX·February 28, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 9, 2012

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·August 27, 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