42 results · 26ms · Sources: EU EUDAMED, US FDA

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ABBOTT ARCHITECT TSH

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALINITY I TSH REAGENT KIT

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

ALINITY I TSH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·November 5, 2025

ALINITY I TSH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·September 15, 2025

ARCHITECT TSH

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·September 5, 2025

ARCHITECT TSH REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·November 19, 2024

CORRIDOR FIXATION SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

ARGENCO 58 TYPE III DENTAL GOLD ALLOY

FDA 510(k)
FDA Class 2 ·Dental

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

HEARTSTART XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2014

TENSION FREE VAGINAL TAPE

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