BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    DIRECTATEX STREP A

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Affirm Lateral Arm Upright Biopsy Accessory

    FDA 510(k)
    FDA Class 2 ·Radiology

    OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·October 8, 2010

    SPECTRUM INFUSION PUMP

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

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·December 7, 2012

    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