235 results · 29ms · Sources: EU EUDAMED, US FDA

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CUROS PORT PROTECTOR

FDA 510(k)
FDA Class 2 ·General Hospital

PENUMBRA CATHERER 025

FDA 510(k)
FDA Class 2 ·Cardiovascular

MONOBOND PLUS

FDA 510(k)
FDA Class 2 ·Dental

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

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013

ACRYSOF TORIC

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 8, 2011

5.5MM POLYAXIAL SCREW-OPEN 6.5 X 55

FDA Adverse Event
Malfunction ·ABBOTT SPINE·Product code KWQ·September 24, 2008

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

ULTRA CATHETER

FDA Adverse Event
Injury ·CURE MEDICAL LLC·Product code KOD·May 21, 2020

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