BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    NAGASHIMA LIGHT SOURCE UNIT SL-4

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268217081·CUSTOM VEIN PACK

    BK-1520-01 ECONOMY WRIST SUPPORT, CHILD

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CIMILRE Free-T2 Plus

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

    PRIMEADVANCED

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 6, 2012

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·August 27, 2010

    BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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