510(k) Report

FDA applicant

South West Intl., Inc.

Mobile, AL4 decisions1985–19860 recalls

FDA records 4 decisions for South West Intl., Inc. (Mobile, AL) from 1985 to 1986: 4 510(k) clearances. All are in product code HQZ (Frame, Spectacle). 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, ophthalmic panel, where it files most

How often FDA has decided South West Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for South West Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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