BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    MAGNESIUM PROCEDURE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OPTECURE +CCC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    9800

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

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 1, 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