FDA applicant

Unimax Hearing Instruments

Gainesville, TX2 decisions1987–19880 recalls

FDA records 2 decisions for Unimax Hearing Instruments (Gainesville, TX) from 1987 to 1988: 2 510(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 Unimax Hearing Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unimax Hearing Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Unimax Hearing Instruments’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 “Unimax”

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

Unimax Medical Systems, Inc. 7 Unimax Medical Products Co., Ltd. 2

Unimax Hearing Instruments

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Unimax”