131 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DiLumen C2; DiLumen Tool Mount
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Puritan Opti-Swab
FDA UDI
Puritan Medical Products·30609576900144·Opti-Swab 1ml Liquid Amies Transport Medium w/ ...
RESUSCITATION UNIT 105
FDA 510(k)
FDA Class 2
·Anesthesiology
STARLIGHT, MODEL PD9012
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 22, 2015
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 3, 2026
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 18, 2015
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 1, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 28, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 6, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·August 18, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
PENUMBRA SYSTEM JETD REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·May 8, 2019
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 20, 2026
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·October 30, 2015
PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·June 14, 2015
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026