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

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    ACUSON S228, S519 & L558 TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Arm-Type Fully Automatic Digital Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OVALTWIST PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXIMO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014

    SYMBIQ SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 28, 2012

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·June 22, 2015

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED

    FDA Adverse Event
    Death ·COOK IRELAND LTD·Product code ESW·July 11, 2014

    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