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

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    T.R.S.: TOOTH REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    EkoSonic Endovascular Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO THE CROSSER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 10, 2020

    TAXUS? LIBERTÉ?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 24, 2014

    PURITAN BENNETT VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN BENNETT·Product code CBK·November 1, 2010

    TUMESCENT INFILTRATION PUMP

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FRN·November 14, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014

    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