BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    R1361 & R1372 MEASURED EXERCISE EQUIPMENT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CARDIOPULMONARY BYPASS ACCESSORY EQUIP.

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    CERVICAL-VAGINAL SPATULA

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·UNKNOWN·Product code FWM·October 4, 2010

    SILICONE COATED FOLEY TRAY

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code KOD·December 3, 2012

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·July 3, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012