FDA applicant

Mizuho America, Inc.

Beverly, MA5 decisions1996–20222 recalls

FDA records 5 decisions for Mizuho America, Inc. (Beverly, MA) from 1996 to 2022: 5 510(k) clearances. Most are in product codes HCH (Clip, Aneurysm) and HBL (Holder, Head, Neurosurgical (Skull Clamp)). Its devices cite 6 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

2in 2022

2007high 2 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2013

2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mizuho America, 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 USA, Inc. 7

Mizuho America, Inc.

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?

What has been recalled?

Other applicant names beginning “Mizuho”