FDA applicant

Toa Medical Electronics USA, Inc.

Los Alamitos, CA33 decisions1978–19940 recalls

FDA records 33 decisions for Toa Medical Electronics USA, Inc. (Los Alamitos, CA) from 1978 to 1994: 33 510(k) clearances. Most are in product codes GKL (Counter, Cell, Automated (Particle Counter)) and GKZ (Counter, Differential Cell). 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, hematology panel, where it files most

How often FDA has decided Toa Medical Electronics USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Toa Medical Electronics USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Toa Medical Electronics USA, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?