8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LIVERPOOL KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111055·SILICONE MAT FOR K 9-2320
Quantum Blood and Fluid Warming System
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 10, 2014
18 IN ATS CYLINDRICAL CUFF, DUAL PORT/SINGL
FDA Adverse Event
Injury
·ZIMMER SURGICAL·Product code KCY·October 12, 2012
KAPPA 700 DR
FDA Adverse Event
MEDTRONIC MED REL, INC.·Product code DXY·August 10, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025