BEUDAMED
    9 results · 28ms · 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.

    ABBOTT OVULATION PREDICTOR TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·EINO8905109·Sterilisation box universal for OSS sterirack

    Snowden-Pencer

    FDA UDI
    STERIS CORPORATION·10885403155581·DIAMOND-FLEX 90 DEG ARTICULATING FORCEPS MARYLA...

    DOPPLER FETAL HEARTBEAT RATE DETECTOR

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

    GuttaSil

    FDA 510(k)
    FDA Class 2 ·Dental

    EPIC II VR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·October 29, 2010

    DRIVE MEDICAL

    FDA Adverse Event
    REBORN MEDICAL CO., LTD.·Product code ITJ·December 26, 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