7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
BACSTOP FILTER IRRIGATION SUPPLY KIT
FDA 510(k)
FDA Class 1
·Ophthalmic
SALTO TALARIS TOTAL ANKLE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Withings Thermo (Model SCT01)
FDA 510(k)
FDA Class 2
·General Hospital
ADAPTA DR
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 7, 2010
XCM BIOLOGIC TISSUE MATRIX
FDA Adverse Event
Malfunction
·KENSEY NASH CORPORATION·Product code FTM·December 4, 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