16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOSKELETON(R) TAS
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST Anti-Em
FDA UDI
BSN MEDICAL, INC.·00035664116262·ANTI EM WH S-LO W 6 EN FR ES
Bernafon
FDA UDI
Bernafon AG·05711584004869·CT5 CP, VC PS DB CANTEO 5
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213026315·microSelectron Transfer Tube for 5F Flexibles (30)
CONCORD 72
FDA 510(k)
FDA Class 2
·Dental
LENSX LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·November 17, 2016
PINN MAR +4 10D 22.225IDX56OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 14, 2013
XXL BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·June 2, 2011
MAVERICK OVER-THE-WIRE PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·August 13, 2008
G7 DUAL MOBILITY ACETABULAR SYSTEM DUAL MOBILITY LINER 38MM C
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 7, 2025
VIVACIT-E DM BEARING 28X38MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 7, 2025
BIOLOX DELTA CERAMIC OPTION HD 28MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 8, 2025
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 25, 2015
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