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FDA device clearances in Alabama

Every FDA 510(k) decision for applicants based in Alabama 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 Alabama were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.

DecidedApplicantDeviceAreaWhereRecord
2026-08-05HCS Innovation, LLCNaturaJel™ Oral Wound Care Kit OLRUnknownUnion Grove, AlabamaK260120
2026-07-06Hartman Medical Group, LLCMicropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) DYBCardiovascularBirmingham, AlabamaK261529
2026-06-26BioHorizons Implant Systems, Inc.BioHorizons CEREC Compatible Ti-Bases NHADentalBirmingham, AlabamaK260061
2026-01-16Curiteva, Inc.Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System ODPOrthopedicTanner, AlabamaK252205
2026-01-15Curiteva, Inc.Curiteva Porous PEEK Cervical Interbody Fusion System ODPOrthopedicTanner, AlabamaK254061

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