8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRANDIO CORE DUAL CURE
FDA 510(k)
FDA Class 2
·Dental
ZIMMER PERIARTICULAR SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOINSIGHT
FDA 510(k)
FDA Class 2
·Radiology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·May 14, 2013
EXT SET 7IN REM CLAVE SITE NDEHP
FDA Adverse Event
HOSPIRA LTD.·Product code FPK·March 8, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025