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

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    MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIAGNOSOFT HARP

    FDA 510(k)
    FDA Class 2 ·Radiology

    DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

    FDA 510(k)
    FDA Class 2 ·Radiology

    POLIGRIP REGULAR

    FDA Adverse Event
    Malfunction ·Product code KOL·October 5, 2010

    SPECTRUM INFUSION PUMP

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

    INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES INC·Product code MEA·November 30, 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