223 results · 38ms · Sources: EU EUDAMED, US FDA

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TDX ETHANOL

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMK SPHERE EXTENSION

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2023

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 29, 2019

GMK SPHERE IMPLANTS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 4, 2025

GREENLIGHT MOXY FIBER OPTIC

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 30, 2014

UNKNOWN DEPUY ASR FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·November 20, 2012

ACCESS

FDA Adverse Event
Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·June 12, 2015

GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2022

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2021

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 30, 2019

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 30, 2022

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 6, 2025

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2023

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 21, 2025

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 9, 2022

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 14, 2021

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 5, 2023