BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    INTRALIG

    FDA 510(k)
    FDA Class 2 ·Dental

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377018359·RELINE-C Screw, 3.5x36mm FA PT

    NUAMPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    ASTRA TOTAL PROTEIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 28, 2014

    OLYMPUS

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL CO. LTD.·Product code FDS·August 21, 2008

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·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