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

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    HSV-1 ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GELSKIN

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EpiLaze Multi-wavelength Laser

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AMS RETROARC RETROPUBIC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTN·June 24, 2014

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·November 4, 2010

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·December 21, 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