89 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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AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPIRA-C
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPC1020370·Trial,12mm x 14.5mm Lordotic 7°, 9mm
SPIRA-L
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPL1020370·Trial, Bi-Convex, 15° Lordotic, 22 x 60mm, 12mm
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020370·SPIRA®-A Integrated,Trial, 26x34mm, 15° Lordoti...
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
FDA 510(k)
FDA Class 2
·Dental
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
FDA 510(k)
FDA Class 2
·Anesthesiology
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
BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 15, 2022
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