10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
OXYGEN TUBINGS
FDA 510(k)
FDA Class 1
·Anesthesiology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788231420·The 2 Level Tray
CONPHAR VELCRO TOUNIGUER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Coltolux Comfort LED Curing Light
FDA 510(k)
FDA Class 2
·Dental
HAKIM VALVE WITH INLINE RESERVOIR
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·May 21, 2013
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 21, 2014
HI-TORQUE SPARTACORE GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·November 7, 2012
ANTI-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·September 1, 2010
HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF·Product code JXG·June 25, 2014
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012