FDA applicant

Nemoto Kyorindo Co., Ltd.

Tokyo, JP8 decisions2005–20240 recalls

FDA records 8 decisions for Nemoto Kyorindo Co., Ltd. (Tokyo, JP) from 2005 to 2024: 8 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and IZQ (Injector, Contrast Medium, Automatic). Its devices cite 16 predicates, 5 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Nemoto Kyorindo Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 2 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Nemoto Kyorindo Co., Ltd.

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?