FDA applicant

Axon Medical

Salt Lake City, UT2 decisions2005–20101 recall

FDA records 2 decisions for Axon Medical (Salt Lake City, UT) from 2005 to 2010: 2 510(k) clearances. All are in product code CBN (Apparatus, Gas-Scavenging). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Axon Medical, Inc.”.

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

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

How often FDA has decided Axon Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Axon Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Axon”

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

Axon Systems, Inc. 15 Axon Instruments, Inc. 3 Axon Spine Medical System 1 Axon Medical Technologies Corp. 1

Axon Medical

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 “Axon”