FDA applicant

The Orvis Co., Inc.

Manchester, VT9 decisions1994–19950 recalls

FDA records 9 decisions for The Orvis Co., Inc. (Manchester, VT) from 1994 to 1995: 9 510(k) clearances. All are in product code 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 The Orvis Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Orvis Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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The Orvis Co., Inc.

Which product codes does it file in?

What has FDA decided for it lately?