BEUDAMED
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    THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET

    FDA 510(k)
    FDA Class 2 ·Immunology

    6F TAIGA GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wireless Digital Flat Panel Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 20, 2025

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 18, 2026

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 3, 2026

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 5, 2026

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 16, 2026

    ALINITY I TSH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·March 20, 2026

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 28, 2026

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 17, 2026

    ALINITY I TSH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·April 16, 2026

    ARCHITECT TSH

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·April 15, 2026

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JFY·February 28, 2013

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 10, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 7, 2014

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·October 23, 2025

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·October 30, 2025

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·July 30, 2025