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