FDA applicant

Roseburg SA

Washington, DC24 decisions1985–19940 recalls

FDA records 24 decisions for Roseburg SA (Washington, DC) from 1985 to 1994: 24 510(k) clearances. Most are in product codes HQZ (Frame, Spectacle) and HQY (Sunglasses (Non-Prescription Including…). 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 Roseburg SA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Roseburg SA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Roseburg SA

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?