7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TRANSPORT INCUBATOR 185
FDA 510(k)
FDA Class 2
·General Hospital
Total Knee Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
REM440
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DVR LOCK NARROW MINI L
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXT·June 5, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 2012
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·June 17, 2015
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