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

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    INHALATOR MODELS 8100, 10100 AND 10200

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYPERVISOR VI CENTRAL MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    12/14 ARTICUL 40MM M SPEC+8.5

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code LPH·December 7, 2012

    VISUALASE THERMAL THERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·BIOTEX, INC.·Product code GEX·March 3, 2014

    CVC SET: 3-LUMEN 12 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code FOZ·June 23, 2015

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016

    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