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

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    ULTRACHEM URIC ACID AIDH #65047

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRIMUS Healthcare Sterilizer (Model PSS11-HC)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER

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

    ELECSYS FSH

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CGJ·September 19, 2025

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 6, 2012

    CLARION

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·August 24, 2010

    ELECSYS AFP

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LOJ·June 13, 2025

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    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