16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZIMMER PERIARTICULAR SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032750·Coupling Treatment Tube for Metal Needles (7)
IN SPACE 3D
FDA 510(k)
FDA Class 2
·Radiology
ECHOINSIGHT
FDA 510(k)
FDA Class 2
·Radiology
RX BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·May 14, 2013
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTL, LTD.·Product code KWA·May 13, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019
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