FDA applicant

Tomey Corporation

Nagoya, JP6 decisions2002–20250 recalls

FDA records 6 decisions for Tomey Corporation (Nagoya, JP) from 2002 to 2025: 6 510(k) clearances. Most are in product codes OBO (Tomography, Optical Coherence) and NQE (Microscope, Specular). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Tomey Corp.”.

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 Tomey Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007high 2 (2025) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tomey Corporation’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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Other applicant names beginning “Tomey”

FDA records each applicant name separately; these may or may not be the same firm.

Tomey Corporation USA 10

Tomey Corporation

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Tomey”