8 results
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19ms
·
Sources: EU EUDAMED, US FDA
RED CELL LYSING REAGENT 78N 1915-1
FDA 510(k)
FDA Class 1
·Hematology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223240·Cervical Trial 6x18x14 Lordotic
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VPAP S-A
FDA 510(k)
FDA Class 2
·Anesthesiology
UNIDENTIFIED ASR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·May 20, 2014
PLASMABLADE TISSUE DISSECTION DEVICE
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·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