13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RSP GLENOID BASEPLATE POROUS COATED
FDA 510(k)
FDA Class 2
·Orthopedic
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...
4200
FDA UDI
HANS RUDOLPH, INC.·00874750008049·4200C MS.875FB 1.375OD/1.375ID
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
FDA 510(k)
FDA Class 2
·Neurology
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
FDA 510(k)
FDA Class 2
·Orthopedic
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 8, 2013
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 7, 2013
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 7, 2013
UNKNOWN DEPUY SROM SLEEVE
FDA Adverse Event
Injury
·DEPUY (IRELAND)/REG. #9616671·Product code KWA·May 14, 2013
AXIOS DR
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO·Product code DXY·August 5, 2008
CD HORIZON
FDA Adverse Event
Injury
·MDT SWINNEA DC·Product code KWP·June 2, 2011
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