FDA applicant

Cd Leycom BV

Zoetermeer, NL3 decisions2001–20030 recalls

FDA records 3 decisions for Cd Leycom BV (Zoetermeer, NL) from 2001 to 2003: 3 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and OBJ (Catheter, Ultrasound, Intravascular). 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, cardiovascular panel, where it files most

How often FDA has decided Cd Leycom BV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cd Leycom BV since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Cd Leycom BV

Which product codes does it file in?

What has FDA decided for it lately?