13 results · 21ms · Sources: EU EUDAMED, US FDA

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TOKUYAMA CUREGRACE

FDA 510(k)
FDA Class 2 ·Dental

ENSITE VELOCITY SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

STRAUMANN P.004 RC GOLD ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

NC QUANTUM APEX PTCA DILATATION CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 21, 2011

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 24, 2013

S-ICD SYSTEM

FDA Adverse Event
Injury ·CAMERON HEALTH·Product code NVY·October 9, 2014

QUATERA 700 BIMANUAL I/A HANDPIECE SET

FDA Adverse Event
Injury ·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2025

GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 23, 2023

GMK-HINGE FEMORAL COMPONENT SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022

GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L

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

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019

ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023