BEUDAMED
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    ALBUMIN PROCEDURE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRIDENT CONSTRAINED ACETABULAR INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NuFACE Gel Primer

    FDA 510(k)
    FDA Class 2 ·Neurology

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·June 10, 2014

    VIRTUOSO II DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010

    SPECTRA OPTIA

    FDA Adverse Event
    TERUMO BCT·Product code LKN·December 7, 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