BEUDAMED
    5,209 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    INSPIRE SLEEP APNEA INNOVATION

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS INC·Product code MNQ·April 7, 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 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 II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).

    FDA Recall
    Terminated ·Inspire Medical Systems Inc.·Product code MNQ·June 12, 2018

    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

    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

    Inspire Model 3028, IV Implantable Pulse Generator

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

    INSPIRE MODEL 4063 STIMULATION LEAD

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS INC.·Product code MNQ·December 1, 2016

    INSPIRE

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS INC·Product code MNQ·October 5, 2017

    INSPIRE MODEL 3028 IPG

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·April 9, 2021

    INSPIRE MODEL 3028 IPG

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·April 9, 2021

    INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·May 10, 2021

    INSPIRE MODEL 3028 IPG

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·June 11, 2021

    INSPIRE MODEL 3028 IPG

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·April 30, 2021

    INSPIRE MODEL 3028 IPG

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·April 19, 2021

    INSPIRE MODEL 3028 IPG

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·June 11, 2021

    INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·June 22, 2021

    INSPIRE MODEL 3028 IPG

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·June 11, 2021

    INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD

    FDA Adverse Event
    Injury ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·April 1, 2021

    INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD

    FDA Adverse Event
    Malfunction ·INSPIRE MEDICAL SYSTEMS·Product code MNQ·June 22, 2021