2 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·June 24, 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