510(k) Report

FDA applicant

Oms

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Oms (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code HPG (Aid, Vision, Electronic, Battery-Powered). 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 Oms’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oms since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HPGAid, Vision, Electronic, Battery-Powered1decision

What has FDA decided for it lately?

The one decision as Oms →