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

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    PICOSCALE BLOOD CELL COUNTER, MODEL PS-5

    FDA 510(k)
    FDA Class 2 ·Hematology

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·Product code FPA·May 11, 2024

    X-MIND trium

    FDA 510(k)
    FDA Class 2 ·Radiology

    OHMEGA

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

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·November 21, 2012

    REPLACEMENT TUBE

    FDA Adverse Event
    Malfunction ·ABBOTT NUTRITION·Product code KNT·September 21, 2010

    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