BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Medtronic Transportation / Sterilization Cassettes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPECTRA THERAPEUTIC PLASMA EXCHANGE SET

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

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 21, 2012

    ATLAS II PLUS DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 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