15 results
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18ms
·
Sources: EU EUDAMED, US FDA
SPI-RISE
FDA 510(k)
FDA Class 2
·Anesthesiology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223590·Cervical Trial 9x18x14 Convex
Quicktome Software Suite
FDA 510(k)
FDA Class 2
·Radiology
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
FDA 510(k)
FDA Class 2
·Microbiology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970515·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970522·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973127·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973554·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973011·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970539·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973417·
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2014
PLASMABLADE TISSUE DISSECTION DEVICE
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2015
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