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FDA device clearances in Nebraska

Every FDA 510(k) decision for applicants based in Nebraska in the last 12 months, with the device, the product area and FDA's own record.

Decisions5
Applicants4

5 premarket notifications (510(k)s) from applicants based in Nebraska were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.

DecidedApplicantDeviceAreaWhereRecord
2026-08-20Virtual IncisionMIRA Surgical System SABGeneral, Plastic SurgeryLincoln, NebraskaK260817
2026-03-27Streck, LLCMDx-Chex for BCP PMNMicrobiologyLa Vista, NebraskaK260041
2026-03-23StreckMDx-Chex for BCN PMNMicrobiologyLa Vista, NebraskaK254166
2026-03-17Streck, LLCMDx-Chex for BCY PMNMicrobiologyLa Vista, NebraskaK254167
2026-01-12Empower Ride, LLCEmpowerRide NAVIGATOR IORPhysical MedicineElkhorn, NebraskaK251886

Where this comes from

Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.

A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.

All device clearances

Cite this page

Permanent URL: https://mentionfox.com/fda/510k/state/ne
Last updated 2026-10-18
FDA device clearances in Nebraska: 5 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/ne