510(k) Report

FDA applicant

Pro Design Intl. AS

New York, NY2 decisions1984–19840 recalls

FDA records 2 decisions for Pro Design Intl. AS (New York, NY) in 1984: 2 510(k) clearances. Most are in product codes HOJ (Screen, Tangent, Target) and 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 Pro Design Intl. AS’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pro Design Intl. AS since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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