BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    AXIPUMP MANUAL BREAST PUMP

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTR·August 16, 2012

    PERCUTANEOUS ENTRY NEEDLE, SELDINGER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STAXX(R) IB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MALLINKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·August 17, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 19, 2014

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code NEK·November 2, 2012

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 25, 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