FDA applicant

Mizuho USA, Inc.

San Diego, CA7 decisions1993–20061 recall

FDA records 7 decisions for Mizuho USA, Inc. (San Diego, CA) from 1993 to 2006: 7 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and DHA (System, Test, Human Chorionic Gonadotropin). 1 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Mizuho USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mizuho USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Mizuho”

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

Mizuho America, Inc. 5

Mizuho USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Mizuho”