510(k) Report

FDA applicant

Van Dellen, Ltd.

Tucson, AZ7 decisions1987–19880 recalls

FDA records 7 decisions for Van Dellen, Ltd. (Tucson, AZ) from 1987 to 1988: 7 510(k) clearances. Most are in product codes HMX (Cannula, Ophthalmic) and HNY (Cystotome). 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 Van Dellen, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Van Dellen, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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