BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    URINARY DRAINAGE BAG

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EMBRYOGEN

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

    VISUALINE BARBITURATES DIPSTRIP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·April 3, 2014

    LIGACLIP MCA LARGE APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDO·October 30, 2007

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 2, 2012

    LAPIPLASTY SYSTEM S4A

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025

    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