3 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Recall
Completed
·Accuray Incorporated·Product code IYE·August 3, 2023
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
FDA Recall
Completed
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·June 19, 2023