FDA applicant

Nidek Medical Products, Inc.

Birmingham, AL12 decisions1988–20207 recalls

FDA records 12 decisions for Nidek Medical Products, Inc. (Birmingham, AL) from 1988 to 2020: 12 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 8 predicates, 5 of them its own earlier devices. 7 recalls are linked to its devices, 7 Class I.

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

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

How often FDA has decided Nidek Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

7in 2012

2007high 7 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Nidek”

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

Nidek, Inc. 100 Nidek Technologies Srl 5

Nidek Medical Products, 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 “Nidek”