BEUDAMED
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    ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GE 1.5T SIGNA HDX MR SYSTEM

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS, LLC·Product code LNH·December 13, 2023

    DEPUY ICN.

    FDA Adverse Event
    Injury ·DEPUY INC.·Product code JDN·December 16, 1997

    ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CONNECTA PLUS3 BLUE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·October 27, 2025

    2008T HD SYS. CDX BLUE STAR

    FDA Adverse Event
    Injury ·ERIKA DE REYNOSA, S.A. DE C.V.·Product code KDI·May 28, 2026

    3.5FR URETHANE UMB CATH

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FOS·September 1, 2016

    2008T HD SYS. W/O CDX W/BIBAG BLUE STAR

    FDA Adverse Event
    Death ·ERIKA DE REYNOSA, S.A. DE C.V.·Product code KDI·February 25, 2026

    2008T MACHINE

    FDA Adverse Event
    Injury ·ERIKA DE REYNOSA, S.A. DE C.V.·Product code KDI·April 10, 2025

    CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM 1.9MM

    FDA Adverse Event
    CODMAN AND SHURTLEFF, INC.·Product code JXG·March 27, 2014

    N-LITE

    FDA Adverse Event
    Other ·ICN PHOTONICS·Product code GEX·April 6, 2003

    N-LITE LASER

    FDA Adverse Event
    Other ·ICN PHOTONICS·Product code GEX·April 6, 2003

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FRN·November 15, 2018

    DRAGER/AIRSHIELDS

    FDA Adverse Event
    Malfunction ·*·Product code FMZ·March 6, 2006

    MEDTRONIC - SOFAMER DANEK

    FDA Adverse Event
    Other ·MEDTRONIC·Product code HTW·April 5, 2006

    INTELLIVUE MX500 PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 28, 2019

    2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS

    FDA Adverse Event
    Injury ·ERIKA DE REYNOSA, S.A. DE C.V.·Product code KDI·April 2, 2025

    TRUE RESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, ICN.·Product code LFR·August 6, 2015

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, ICN.·Product code LFR·July 1, 2015