BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    V100 VISUALLY EVOKED POTENTIAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981127626·20x15x10mm, 15 Degree Trial

    POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Elecsys Syphilis

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SELECTSECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·June 10, 2014

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 7, 2010

    ASR ACETABULAR CUPS 60

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 6, 2012

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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