3 results
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41ms
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Sources: EU EUDAMED, US FDA
SLEEPM GLOBAL INC
FDA registration
SLEEPM GLOBAL INC·3 products·🇺🇸 United States
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
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices