FDA applicant

Corneagen, Inc.

Winston-Salem, NC2 decisions2015–20221 recall

FDA records 2 decisions for Corneagen, Inc. (Winston-Salem, NC) from 2015 to 2022: 1 510(k) clearance and 1 original PMA approval. Most are in product codes OTZ (Graft Insertion Instrument For Endothelial…) and LQE (Implant, Corneal, Refractive). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Corneagen”.

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 Corneagen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2016

2015high 1 (2016) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Corneagen, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Corneagen, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?