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

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    HPS II SMOOTH STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SULFACYTINE 0.25 MG.

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BISCEM TRANSLUCENT, BISCEM OPAQUE

    FDA 510(k)
    FDA Class 2 ·Dental

    PROTECTA XT CRT-D

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

    CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·October 7, 2010

    DISSECTOR, 4.0MM X 13CM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code GFA·December 6, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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