9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARGYLE CAROTID ARTERY LOOP SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223170·Cervical Trial 7x16x13 Lordotic
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
FDA 510(k)
FDA Class 2
·General Hospital
TETRIS II
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2014
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER 45MM STAPLE LINE 3.5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GDW·December 6, 2007
SPINE IMPLANT
FDA Adverse Event
Injury
·Product code MNI·November 7, 2012
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
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