7 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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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
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
FDA Recall
Terminated
·Alto Development Corp·Product code JDQ·September 10, 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
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 Recall
Terminated
·Biomet UK Ltd. Waterton Industrial Estate Bridgend United Kingdom·Product code JDO·August 9, 2018
Magnetom Sonata MRI System, Model 7388148
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·July 28, 2004
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