FDA applicant

Tomey Corporation USA

Cambridge, MA10 decisions1991–20020 recalls

FDA records 10 decisions for Tomey Corporation USA (Cambridge, MA) from 1991 to 2002: 10 510(k) clearances. Most are in product codes HJO (Biomicroscope, Slit-Lamp, Ac-Powered) and HKY (Tonometer, Manual). Its devices cite 12 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

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

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

FDA decisions per year

No FDA decision for Tomey Corporation USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tomey Corporation USA’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 6

Tomey Corporation USA

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Tomey”