34 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STACLOT(R) PROTEIN S TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
LOFRIC SINGLE USE URINARY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
FDA 510(k)
FDA Class 2
·Orthopedic
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
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 12, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 3, 2014
ANCHOR FAST
FDA Adverse Event
HOLLISTER·Product code CBH·November 2, 2012
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 15, 2024
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·October 23, 2025
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·October 30, 2025
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·July 30, 2025
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·September 12, 2025
ARCHITECT TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 9, 2025