62 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GYRUS ACMI
FDA UDI
Gyrus ACMI, LLC·00821925018419·RICHARDS PISTON 3.5 MM LENGTH .8MM DIAMETER PLA...
Universal Abutment
FDA UDI
BICON, LLC·00813110029362·Universal Abutment UA4 SP 0° - 2.0mm Tall Post
MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
FDA 510(k)
FDA Class 2
·Anesthesiology
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
FDA 510(k)
FDA Class 2
·Hematology
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
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2025
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