FDA applicant

Sonex Health, Inc.

Rochester, MN2 decisions2019–20251 recall

FDA records 2 decisions for Sonex Health, Inc. (Rochester, MN) from 2019 to 2025: 2 510(k) clearances. Most are in product codes LXH (Orthopedic Manual Surgical Instrument) and HRX (Arthroscope). 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 “Sonex Health”.

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 Sonex Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2022

2019high 1 (2022) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Sonex Health, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sonex Health, Inc.’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 “Sonex”

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

Sonex Intl., Corp. 1 Sonex Medical 1

Sonex Health, Inc.

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 “Sonex”