8 results
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77ms
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Sources: EU EUDAMED, US FDA
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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 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
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
MAMMOMAT Inspiration Full field digital mammographic x-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MUE·September 15, 2011
Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
FDA Recall
Terminated
·Mindray DS USA, Inc., dba Datascope Patient Monitoring·Product code BSZ·March 5, 2010