8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SYVA ADVANCE EMIT AED VALPROIC ACID CONT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788229340·13 mm Small Hudson Shaver
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
FDA 510(k)
FDA Class 2
·Anesthesiology
Nanox.ARC
FDA 510(k)
FDA Class 2
·Radiology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·May 21, 2014
SPEEDLOCK IMPLANT
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code MBI·October 23, 2012
XPH170 SYNTHETIC HF DIALYZERHF DIALYZER
FDA Adverse Event
Injury
·NIPRO CORPORATION *USD*·Product code KDI·September 1, 2010
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