BEUDAMED
    36 results · 31ms · Sources: EU EUDAMED, US FDA

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    THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO

    FDA 510(k)
    FDA Class 2 ·Immunology

    LANCET, BLOOD

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDONIC M SERIES

    FDA 510(k)
    FDA Class 2 ·Hematology

    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

    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

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·February 28, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

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

    G7 OSSEOTI MULTIHOLE 68MM I

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 13, 2019

    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

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·September 12, 2025

    ARCHITECT TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 9, 2025