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

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    ENZYGNOST ANTI-CMV IGM TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Arsenal Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGILIS NXT STEERABLE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.·Product code DYB·March 29, 2024

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 8, 2010

    TALENT STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 7, 2012

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 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