FDA applicant

Nidek Technologies Srl

Albignasego (Padova), IT5 decisions2001–20122 recalls

FDA records 5 decisions for Nidek Technologies Srl (Albignasego (Padova), IT) from 2001 to 2012: 5 510(k) clearances. Most are in product codes HKI (Camera, Ophthalmic, Ac-Powered) and HJO (Biomicroscope, Slit-Lamp, Ac-Powered). Its devices cite 9 predicates, 3 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, ophthalmic panel, where it files most

How often FDA has decided Nidek Technologies Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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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 Medical Products, Inc. 12

Nidek Technologies Srl

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”