7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CEMAX SCANLINK V
FDA 510(k)
FDA Class 2
·Radiology
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
FDA 510(k)
FDA Class 2
·Anesthesiology
CastleLoc Pectus Bar System
FDA 510(k)
FDA Class 2
·Orthopedic
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 5, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 1, 2011
GUIDE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code FZX·July 18, 2014
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