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

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    MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LMT NOMAG IC 3.0

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sentinella 102, Sentinella 102 Horus

    FDA 510(k)
    FDA Class 1 ·Radiology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 23, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012

    JARIT

    FDA Adverse Event
    Malfunction ·INTEGRA SURGICAL·Product code HDC·September 27, 2010

    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