BEUDAMED
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    MEDISYSTEMS PHERESIS NEEDLE

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

    K2-HF OPAQUER powder, O-A2, 20g.

    FDA UDI
    Yeti Dentalprodukte GmbH·EYET38620020·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190646·Femoral Sizing Guide Bushing 3 deg +2mm

    URINE SPECIMEN CONTAINER #'S 1013-1016

    FDA 510(k)
    FDA Class 1 ·Pathology

    Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 22, 2014

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 7, 2012

    RESTORESENSOR MRI

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 23, 2015

    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