17 results · 23ms · Sources: EU EUDAMED, 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