FDA applicant

Optex Biomedical

The Woodlands, TX1 decision1990–19900 recalls

FDA records 1 decision for Optex Biomedical (The Woodlands, TX) in 1990: 1 510(k) clearance. All are in product code CCE (Analyzer, Gas, Oxygen, Partial Pressure…). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Optex Biomedical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Optex Biomedical

Which product codes does it file in?

What has FDA decided for it lately?