35 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VINYL EXAM GLOVES, POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
ULTIMA FIVE
FDA 510(k)
FDA Class 2
·Neurology
R190/R191 LCD Monitor
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
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2014
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·February 28, 2013
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·January 31, 2011
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
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·June 19, 2025