13 results · 27ms · Sources: EU EUDAMED, US FDA

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COOK MINI-INCUBATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)
FDA Class 3 ·Orthopedic

CODMAN NEUROLASE LASER SYSTEM

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

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

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 28, 2013

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·January 31, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 6, 2014

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