BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACE IM ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUPERCATH 6

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MINICON CONCENTRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·May 10, 2023

    SPRINT

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

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·December 5, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 22, 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