19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
FDA 510(k)
FDA Class 2
·Orthopedic
TIBIAL BLOCK AND SCREWS PRECOAT SIZE 6 5 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·February 6, 2017
MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VINYL ADDITION SILICONE SYSTEM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VGXP INTLK FMRL RT 60
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 10, 2018
VGXP XP E1 TIB BRG RL 9X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 12, 2018
VNGD XP INLK PRI TIB TRAY 69MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 10, 2018
VGXP XP E1 TIB BRG RM 9X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 12, 2018
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·February 6, 2013
LIVIAN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 4, 2011
DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R1.5
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·July 21, 2014
VGXP XP E1 TIB BRG RL 9X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018
VNGD XP INLK PRI TIB TRAY 71MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018
VANGUARD XP TIBIAL BEARING RIGHT LATERAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·October 6, 2017
VGXP INTLK FMRL RT 60
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018
VANGUARD XP TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 4, 2018
VANGUARD XP TIBIAL BEARING RIGHT LATERAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 4, 2018
VANGUARD XP FEMORAL INTERLOK WITH PEGS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 4, 2018
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024