58 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASCEND SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLUORCANASITE DENTAL CERAMIC
FDA 510(k)
FDA Class 2
·Dental
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GMK HINGE FEMUR SIZE 2 RIGHT
FDA Adverse Event
Injury
·Product code KRO·September 12, 2014
GMK HINGE FEMUR SIZE 5 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNAIONAL SA·Product code KRO·August 21, 2014
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 15, 2025
GMK HINGE AND REVISION TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 7, 2025
GMK-HINGE FIXED TIBIAL TRAY SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·October 29, 2020
GMK-REVISION FEMUR REVISION PS SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 11, 2020
GMK-REVISION FEMUR REVISION PS #4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2021
GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 1 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 14, 2016
GMK-REVISION FEMUR REVISION PS SIZE 4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 8, 2016
GMK-REVISION FEMUR REVISION PS SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 7, 2020
GMK-REVISION TIBIAL AUGMENTATION SIZE 4/5MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·October 3, 2019
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 19, 2019
GMK-REVISION, FEMUR REVISION PS #5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 8, 2016
GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2017
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2013
SYNCHRON® LX20 ANALYZER W/O CAP PIERCER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 10, 2011
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·August 15, 2008