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

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Eon Aligner

FDA 510(k)
FDA Class 2 ·Dental

RIGEL 3DR Anterior Cervical Interbody Fusion System

FDA 510(k)
FDA Class 2 ·Orthopedic

CORDLESS COMPACT MOBILE X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023

GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 21, 2023

CELL-DYN 1800 ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 11, 2011

PRIMEADVANCED

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·October 27, 2014

ACCU-CHEK ® COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 2, 2013

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 4, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 18, 2024

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 13, 2024

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 19, 2023

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2025

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2024

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·July 2, 2025