17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Raven Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550193·GENUMEDI PT KNEE SUP SILVER R EW IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814770·GENUMEDI EXTRA WIDE SILVER SIZE IV
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304438200·
FX V 135 stem
FDA UDI
FX SOLUTIONS·03701037315156·FX V 135 stem TA6V Ø32/14 cementless Ti/HA
THERMOPLASTIC INSTRUMENT TRAY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896019386·THERMOPLASTIC INSTRUMENT TRAY SINGLE
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
FDA 510(k)
FDA Class 2
·Cardiovascular
M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
FDA 510(k)
FDA Class 2
·Cardiovascular
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 3, 2008
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
VANGUARD KNEE SYSTEM PS+ TIBIAL BEARING E1 ANTIOXIDANT INFUSED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 15, 2018
VANGUARD PS TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·August 15, 2018
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
PATELLOFEMOROTIBIAL SEMI-CONSTRAINED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 15, 2018
BIOMET CC I-BEAM TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 15, 2018
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025