FDA applicant

Unitron Industries, Inc.

Port Huron, MI69 decisions1976–19970 recalls

FDA records 69 decisions for Unitron Industries, Inc. (Port Huron, MI) from 1976 to 1997: 69 510(k) clearances. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Unitron Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Unitron”

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

Unitron Hearing 1 Unitron Corp. 1

Unitron Industries, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Unitron”