BEUDAMED
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    MX8000 IDT CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    IDT ANA STIQ ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    IDT-1104 IMPLANT (SCREW-IN-THREADED)

    FDA 510(k)
    FDA Class 2 ·Dental

    PROCLEIX ULTRIO ELITE ASSAY

    FDA Adverse Event
    Injury ·GRIFOLS DIAGNOSTIC SOLUTIONS INC.·Product code QHO·July 16, 2024

    PROCLEIX ULTRIO ELITE ASSAY

    FDA Adverse Event
    Injury ·GRIFOLS DIAGNOSTIC SOLUTIONS INC.·Product code QHO·July 16, 2024

    PROCLEIX ULTRIO ELITE ASSAY

    FDA Adverse Event
    Injury ·GRIFOLS DIAGNOSTIC SOLUTIONS INC.·Product code QHO·October 10, 2023

    COBAS® MPX - 192T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 19, 2025

    PROCLEIX ULTRIO ELITE ASSAY

    FDA Adverse Event
    Injury ·GRIFOLS DIAGNOSTIC SOLUTIONS INC.·Product code QHO·August 15, 2025

    MX8000 IDT

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·September 17, 2013

    PROCLEIX ULTRIO ELITE ASSAY

    FDA Adverse Event
    Injury ·GRIFOLS DIAGNOSTIC SOLUTIONS INC.·Product code QHO·May 8, 2026

    COBAS® MPX MULTIPLEX HIV, HCV & HBV NUCLEIC ACID TEST

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025

    TOSOH G8 AUTOMATED HPLC ANALYZER

    FDA Adverse Event
    Injury ·TOSOH HI-TEC, INC.·Product code LCP·September 8, 2011

    VAPR3 GENERATOR *EA

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code GEI·September 25, 2020

    MX 8000 IDT

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·July 8, 2010

    BD VIAL UVT 1 ML WITH BEADS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JSM·July 23, 2020

    VAPR3 GENERATOR *EA

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code GEI·December 26, 2018

    ALINITY S ANTI-HCV REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code QHM·June 4, 2021

    COBAS® MPX - 96T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025

    VAPR3 GENERATOR *EA

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code GEI·March 16, 2020

    COBAS® MPX - 480T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·March 11, 2026