5 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 4, 2026
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
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