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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Oryx Cloud Imaging

FDA 510(k)
FDA Class 2 ·Radiology

gastroduodenal FTRD Set

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FINESUN EMS STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

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

SHILEY, 8DCT 7.6 MM ID 12.2 MM OD 79.0 MM L

FDA Adverse Event
Injury ·NELLCOR·Product code BTO·October 31, 2008

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 23, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 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