14 results · 21ms · Sources: EU EUDAMED, US FDA

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C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)

FDA 510(k)
FDA Class 1 ·Radiology

MODIFICATION TO MICROFUSE BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

MiniGuard Arterial Safety Valve

FDA 510(k)
FDA Class 2 ·Cardiovascular

ALINITY I TSH REAGENT KIT

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

SUPRACONDYLAR NAIL T2 SCN 10 X 200 MM

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS ¿ KIEL·Product code HSB·July 17, 2012

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

36" HIGH FLOW RATE EXT SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·February 9, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 6, 2014

AXSYM HBSAG

FDA Adverse Event
Other ·ABBOTT LABORATORIES·Product code KSJ·September 19, 2007

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