34 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFETEX CERVICAL SCRAPER (PLASTIC)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
FDA 510(k)
FDA Class 2
·Ophthalmic
Avulsion Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·June 27, 2014
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code CEW·February 28, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·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