3 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A
FDA Enforcement
Class II
·Ongoing·Inspire Medical Systems Inc.·June 24, 2026
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
FDA Enforcement
Class II
·Ongoing·Inspire Medical Systems Inc.·October 16, 2024
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021