FDA applicant

Nico-Lab B.V.

Amsterdam, NL2 decisions2020–20230 recalls

FDA records 2 decisions for Nico-Lab B.V. (Amsterdam, NL) from 2020 to 2023: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QAS (Radiological Computer-Assisted Triage And…). Its devices cite 2 predicates, 0 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, radiology panel, where it files most

How often FDA has decided Nico-Lab B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Nico-Lab B.V. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Nico-Lab”

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

Nico Corporation 9 Nico Metal Products Corp. 1

Nico-Lab B.V.

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 “Nico-Lab”