FDA applicant

Fort Defiance Industries, LLC

Loudon, TN3 decisions2014–20253 recalls

FDA records 3 decisions for Fort Defiance Industries, LLC (Loudon, TN) from 2014 to 2025: 3 510(k) clearances. All are in product code FLE (Sterilizer, Steam). Its devices cite 3 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Fort Defiance Industries, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Fort Defiance Industries, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2026

2014high 1 (2018) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Fort Defiance Industries, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fort Defiance Industries, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Fort”

FDA records each applicant name separately; these may or may not be the same firm.

Fort & Assoc. 1

Fort Defiance Industries, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Fort”