FDA applicant

Eyekon Medical, Inc.

Clearwater2 decisions1989–20260 recalls

FDA records 2 decisions for Eyekon Medical, Inc. (Clearwater) from 1989 to 2026: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HQL (Intraocular Lens) and MLP (Keratoprosthesis, Temporary Implant, Surgical…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Eyekon Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2007high 1 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Eyekon Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?