209 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Helianthus
FDA 510(k)
FDA Class 2
·Radiology
Syntec Osteo-plate and screw Fixation
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782853908·Cortex Screw Self-Tappingφ2.7 x L22mm
NA
FDA UDI
Synthes GmbH·10886982144775·2.7MM CORTEX SCREW SELF-TAPPING 22MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113325·PHACO KNIFE 2.8MM ANGLED (BX/5)
IMPLANT-ONE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VERTEX SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 22, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 14, 2026
ACCU-CHEK RAPID D INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·October 14, 2008
SIGMA 300 DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 2, 2013
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 3, 2024
GMK
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 30, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 5, 2025
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 20, 2024
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 16, 2024
GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S3+L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2024
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 13, 2022
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2024