111 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925012561·SCHUKNECHT DEPTH GAUGE .6 MM DIAMETER
OneStep
FDA UDI
Diagnostic Automation, Inc.·10894175000081·OneStep hCG Combo Urine/Serum RapiCard™ InstaTe...
QMedix™
FDA UDI
Diagnostic Automation, Inc.·00850054026651·QMedix™ hCG Combo Urine/Serum RapiCard™ InstaTe...
GMK HINGE FEMUR SIZE 2 RIGHT
FDA Adverse Event
Injury
·Product code KRO·September 12, 2014
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
FDA 510(k)
FDA Class 2
·Dental
COULTER ACT 5DIFF AUTOLOADER (AL)
FDA 510(k)
FDA Class 2
·Hematology
GMK HINGE FEMUR SIZE 5 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNAIONAL SA·Product code KRO·August 21, 2014
GMK HINGE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·September 4, 2025
GMK HINGE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·May 13, 2026
GMK HINGE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·December 30, 2025
GMK-HINGE FIXED TIBIAL TRAY SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·October 29, 2020
GMK-HINGE 02.09.0523H FIXED TIBIAL INSERT SIZE 5/23MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·October 6, 2023
GMK-HINGE FEMORAL COMPONENT SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2019
GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·July 12, 2019
GMK-HINGE FEMORAL COMPONENT SIZE3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·December 20, 2021
GMK HINGE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·May 13, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026
GMK-HINGE FIXED TIBIAL INSERT SIZE 3/20MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·September 15, 2020
GMK-HINGE FEMORAL COMPONENT SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·August 16, 2018