7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MONITOR, AERATION, TEC-TEST
FDA 510(k)
FDA Class 2
·General Hospital
Tomcat Cervical Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
DEEP FREEZE SYSTEM (DFS-30)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 24, 2014
ACCU-CHEK ACTIVE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·November 13, 2007
FOXCROSS PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·October 3, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015