8 results
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29ms
·
Sources: EU EUDAMED, US FDA
AMERIFLOUR FLUOROMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18218071·
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
V5MS TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 20, 2014
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 5, 2015
RESIDENT BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·August 26, 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