FDA Device Entity Profile: Inspire Medical Systems Inc.

Known Identifiers & Locations

FEI Numbers 3007666314, 3030499299

Owner Operator Numbers 10046749

Locations Covered Golden Valley, MN, US

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3007666314	INSPIRE MEDICAL SYSTEMS INC	Golden Valley, MN, US	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility	View Details
3030499299	Inspire Medical Systems Inc	Golden Valley, MN, US	Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (2)

Recall #	Product Description	Initiation Date	Status	Action
Z-0040-2025	Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system. Reason: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.	2024-07-31	Open, Classified	View Details
Z-0041-2025	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. Reason: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.	2024-07-31	Open, Classified	View Details

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