62 results · 23ms · Sources: EU EUDAMED, US FDA

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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