BEUDAMED
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    TactiFlex™ Sensor Enabled™

    FDA UDI
    ST. JUDE MEDICAL, INC.·05415067052063·Ablation Catheter

    E1-QUEST INHIBITION ASSAY

    FDA Adverse Event
    Injury ·QUEST DIAGNOSTICS·Product code PGI·December 16, 2025

    QUEST INHIBITION ASSAY

    FDA Adverse Event
    Injury ·QUEST DIAGNOSTICS·Product code PGI·December 16, 2025

    M/L TAPER SIZE 9.0 EXTENDED OFFSET

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·November 20, 2017

    QUEST INHIBITION ASSAY

    FDA Adverse Event
    Injury ·QUEST DIAGNOSTICS·Product code PGI·December 16, 2025

    QUEST INHIBITION ASSAY

    FDA Adverse Event
    Injury ·QUEST DIAGNOSTICS·Product code PGI·December 16, 2025

    QUEST INHIBITION ASSAY

    FDA Adverse Event
    Injury ·QUEST DIAGNOSTICS·Product code PGI·December 16, 2025

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·January 8, 2019

    CONTOUR NEXT EZ

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 14, 2012

    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·September 30, 2020

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·May 30, 2012

    ARCHITECT CA19-9

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·May 30, 2012

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·May 30, 2012

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·May 30, 2012

    1415939-2019-00031

    FDA Adverse Event
    Malfunction ·June 10, 2019

    ARCHITECT BNP CALIBRATORS

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code JIT·June 10, 2019

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·November 14, 2016

    HEMOSIL RINSE SOLUTION 4L

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code JJX·October 24, 2016

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·December 16, 2016