7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
C ARM SURGICAL TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MCP Bone Putty
FDA 510(k)
FDA Class 2
·Orthopedic
SEARS ALL-IN-THE-EAR HEARING AID #8149
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code LZH·November 5, 2012
PENUMBRA SYSTEM SEPARATOR FLEX 041
FDA Adverse Event
Malfunction
·PENUMBRA INC.·Product code NRY·September 27, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012