8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
NAUTILUS LEG EXTENSION TESTING & REHABILITATION
FDA 510(k)
FDA Class 2
·Physical Medicine
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981132576·Trial 14x13x6mm, 10 Deg Lordosis, w/ Depth Stop
INTEROSSEOUS NEEDLE
FDA 510(k)
FDA Class 1
·Dental
ACUTE BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
VIRTUOSO DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·June 10, 2014
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 4, 2010
INTRAMEDULLARY BONE PLUG
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 2, 2012
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