FDA applicant

Vision Medical, Inc.

Fremont, CA3 decisions1991–20260 recalls

FDA records 3 decisions for Vision Medical, Inc. (Fremont, CA) from 1991 to 2026: 3 510(k) clearances. Most are in product codes HQE (Instrument, Vitreous Aspiration And Cutting…) and HJM (Transilluminator, Ac-Powered). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “VISION MEDICAL Co., Ltd.”.

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

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Vision Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?