209 results · 23ms · Sources: EU EUDAMED, 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