89 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTHREX FRACTURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006434·2200C 2WAY YSHP 22MMOD/15MMID
DEVILBISS SLEEP RECORDER MODEL # RM60
FDA 510(k)
FDA Class 2
·Anesthesiology
GMK REVISION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-REVISION FEMUR REVISION PS SIZE 6 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2017
GMK-HINGE FIXED TIBIAL TRAY SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·August 28, 2019
GMK HINGE FEMUR SIZE 5 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNAIONAL SA·Product code KRO·August 21, 2014
GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 25, 2017
GMK-REVISION FEMUR REVISION PS SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 19, 2019
GMK HINGE FEMUR SIZE 2 RIGHT
FDA Adverse Event
Injury
·Product code KRO·September 12, 2014
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025
GMK-REVISION FEMUR REVISION PS SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 6, 2018
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 12, 2017
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 15, 2025
GMK-HINGE FIXED TIBIAL TRAY SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·April 7, 2020
GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 1 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 14, 2016
GMK-HINGE TIBIAL AUGMENTATION SIZE 5/5MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KRO·August 31, 2018
GMK-REVISION FEMUR REVISION PS SIZE 3 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 19, 2017
GMK-REVISION FEMUR REVISION PS SIZE4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 25, 2020
GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 23, 2018