BEUDAMED
    3 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Ongoing·Augustine Temperature Management, LLC·February 26, 2025

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Ongoing·Augustine Temperature Management, LLC·February 26, 2025

    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