5 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips North America Llc·August 25, 2021
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·November 6, 2019
HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
FDA Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 2018
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013