FDA applicant

Dutch Ophthalmic Research Center International BV

Zuidland, NL4 decisions2006–20170 recalls

FDA records 4 decisions for Dutch Ophthalmic Research Center International BV (Zuidland, NL) from 2006 to 2017: 4 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and MPA (Endoilluminator). Its devices cite 14 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 Research Center International BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Dutch”

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

Dutch Ophthalmic USA, Inc. 10 Dutch Ophthalmic Research Center (D.O.R.C.) 1

Dutch Ophthalmic Research Center International BV

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”