8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOGRAPH MCT FAMILY
FDA 510(k)
FDA Class 2
·Radiology
BRIVO XR385
FDA 510(k)
FDA Class 2
·Radiology
PRISMASATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
R3 XLPE INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025
NEXGEN FLUTED STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·May 31, 2011
DAVINCI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·April 29, 2013
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·September 24, 2014
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021