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