BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    KLEEN TEST O.R. KIT

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

    Endophys Pressure Sensing Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STRYKER ORTHOPEDICS

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS·Product code JWH·June 2, 2014

    LC PCA NEW 802.11 AB

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·October 22, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012

    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