64 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARI-PASS VARIABLE LENGTH ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK REVISION KNEE SC LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 26, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 4, 2021
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 15, 2026
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 30, 2025
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE·Product code IOR·May 21, 2013
MINILINK TRANSMITTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·September 26, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·June 10, 2011
GMK-REVISION FEMUR REVISION PS SIZE 1 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 11, 2020
GMK-REVISION TINBN COATED FEMUR REVISION PS SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 21, 2023
GMK-REVISION FEMUR REVISION PS SIZE 6 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2021
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 31, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 12, 2020
GMK-REVISION - REVISION TIBIAL TRAY SIZE 2 RIGHT - FINISHING
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 23, 2024
GMK-REVISION FEMUR REVISION PS SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2019
GMK-REVISION FEMUR REVISION PS SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 26, 2022
GMK-REVISION TIBIAL TRAY CEMENTED SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 5, 2020
GMK REVISION TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 27, 2026