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

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    PHYSICAL MEDICINE & REHABILITATION EQUIP

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788229060·Small Hudson TLIF Trial 8x10x32

    Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RESQPOD CIRCULATORY ENHANCER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PLUM A+ DRIVER NEW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 5, 2014

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·November 7, 2012

    REALIZE ADJ GASTRIC BAND-C

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·September 1, 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