FDA applicant

Sonex Medical

Salt Lake City, UT1 decision1989–19890 recalls

FDA records 1 decision for Sonex Medical (Salt Lake City, UT) in 1989: 1 510(k) clearance. All are in product code LDR (Controller, Infusion, Intravascular, Electronic). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Sonex Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sonex 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 “Sonex”

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

Sonex Health, Inc. 2 Sonex Intl., Corp. 1

Sonex Medical

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sonex”