FDA applicant

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

Zuidland, NL2 decisions2019–20227 recalls

FDA records 2 decisions for D.O.R.C. Dutch Ophthalmic Research Center (International) (Zuidland, NL) from 2019 to 2022: 2 510(k) clearances. All are in product code HQC (Unit, Phacofragmentation). Its devices cite 8 predicates, 1 of them its own earlier devices. 7 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 D.O.R.C. Dutch Ophthalmic Research Center (International)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

3in 2026

2019high 3 (2024) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — D.O.R.C. Dutch Ophthalmic Research Center (International) by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like D.O.R.C. Dutch Ophthalmic Research…’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 “D.O.R.C.”

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

D.O.R.C. Intl. B.V. 1

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

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 “D.O.R.C.”