8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Retitrack
FDA 510(k)
FDA Class 2
·Ophthalmic
COOK INJECTION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cordera Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
BINAX NOW COVID-19 AG CARD KIT 40T EUA
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 7, 2023
MBT CEM KEEL TIB TRAY SZ2.5
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS.·Product code NJL·November 5, 2008
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 13, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025