BEUDAMED
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    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

    FDA Recall
    Open, Classified ·Inspire Medical Systems Inc.·Product code MNQ·May 11, 2026

    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 Recall
    Open, Classified ·Inspire Medical Systems Inc.·Product code MNQ·May 11, 2026

    Inspire Model 3028, IV Implantable Pulse Generator

    FDA Recall
    Open, Classified ·Inspire Medical Systems Inc.·Product code MNQ·May 16, 2024

    Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

    FDA Recall
    Open, Classified ·Inspire Medical Systems Inc.·Product code MNQ·July 31, 2024

    Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

    FDA Recall
    Open, Classified ·Inspire Medical Systems Inc.·Product code MNQ·July 31, 2024

    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

    FDA Recall
    Open, Classified ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·February 14, 2023

    BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code PHC·August 4, 2020