FDA applicant

Nitto Denko America, Inc.

Santa Clara, CA5 decisions1985–19870 recalls

FDA records 5 decisions for Nitto Denko America, Inc. (Santa Clara, CA) from 1985 to 1987: 5 510(k) clearances. Most are in product codes KGX (Tape And Bandage, Adhesive) and DRX (Electrode, Electrocardiograph). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Nitto Denko America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Nitto”

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

Nitto Denko Technical Corp. 1

Nitto Denko America, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Nitto”