13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABBOTT ARCHITECT TOTAL T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CRYOcheck FVIII Inhibitor Kit
FDA 510(k)
FDA Class 2
·Hematology
PRIMATRIX DERMAL REPAIR SCAFFOLD
FDA 510(k)
FDA Unclassified
·Unknown
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
AFFINITY OXY NT 511
FDA Adverse Event
Malfunction
·PERFUSION SYSTEMS·Product code DTZ·February 28, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 6, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·January 31, 2011
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