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

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    LOGIQ E10s, LOGIQ Fortis

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTRAUTEK ORTHOGNATHIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    B4C System

    FDA 510(k)
    FDA Class 2 ·Neurology

    AIR DERMATOME KIT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·April 12, 2013

    CAROTID WALLSTENT MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIM·November 6, 2014

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·September 1, 2011

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 15, 2013

    Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.

    FDA Enforcement
    Class II ·Ongoing·Medagent Inc·March 6, 2024

    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