510(k) Report

FDA applicant

Applied Laboratories, Inc.

Columbus, IN9 decisions1985–19880 recalls

FDA records 9 decisions for Applied Laboratories, Inc. (Columbus, IN) from 1985 to 1988: 9 510(k) clearances. Most are in product codes LRX (Case, Contact Lens) and HPX (Lens, Contact (Polymethylmethacrylate)). 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 Applied Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Applied Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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