FDA applicant

Dutch Ophthalmic USA, Inc.

Kingston, NH10 decisions1990–20010 recalls

FDA records 10 decisions for Dutch Ophthalmic USA, Inc. (Kingston, NH) from 1990 to 2001: 10 510(k) clearances. Most are in product codes MPA (Endoilluminator) and HQE (Instrument, Vitreous Aspiration And Cutting…). Its devices cite 9 predicates, 1 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, ophthalmic panel, where it files most

How often FDA has decided Dutch Ophthalmic USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dutch Ophthalmic USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dutch Ophthalmic USA, 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 “Dutch”

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

Dutch Ophthalmic Research Center International BV 4 Dutch Ophthalmic Research Center (D.O.R.C.) 1

Dutch Ophthalmic USA, 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?

Other applicant names beginning “Dutch”