35 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABBOTT ARCHITECT TOTAL T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517967404·Brigade Lateral, 14x34x24mm 15°
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
FDA 510(k)
FDA Class 2
·Anesthesiology
TT1 GENERAL PURPOSE COIL
FDA 510(k)
FDA Class 2
·Radiology
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
STARDRIVE SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HXX·February 28, 2013
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·January 31, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·July 7, 2014
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