BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC

    FDA 510(k)
    FDA Class 2 ·Dental

    Corin Optimized Position System Functional Hip Analysis (OPS FHA)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EPICARDIA 5000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

    SHILEY

    FDA Adverse Event
    Injury ·COVIDIEN·Product code BTO·June 11, 2014

    COBE SPECTRA TPE SET

    FDA Adverse Event
    Other ·CARIDIANBCT·Product code LKN·October 28, 2010

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 31, 2012

    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