FDA applicant

Armis Biopharma, Inc.

Fort Collins, CO2 decisions2020–20230 recalls

FDA records 2 decisions for Armis Biopharma, Inc. (Fort Collins, CO) from 2020 to 2023: 2 510(k) clearances. Most are in product codes HTY (Pin, Fixation, Smooth) and FQH (Lavage, Jet). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Armis Biopharma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Armis Biopharma, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Armis Biopharma, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?