BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    STATIC STRENGTH TESTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DRILL SLEEVE F. SOLID STEPDRILL

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·February 23, 2012

    MEDTRONIC ENERTRAX MODEL 7100

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONCERTO II CRT-D

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

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 29, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·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