9 results
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35ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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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
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 Enforcement
Class II
·Ongoing·Inspire Medical Systems Inc.·June 24, 2026
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 29, 2014
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 17, 2014
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 8, 2017
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
FDA Enforcement
Class II
·Ongoing·Brainlab AG·March 22, 2023
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
FDA Enforcement
Class II
·Ongoing·Inspire Medical Systems Inc.·October 16, 2024
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
FDA Enforcement
Class II
·Ongoing·Inspire Medical Systems Inc.·October 16, 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 Enforcement
Class II
·Terminated·Inspire Medical Systems Inc.·September 12, 2018