510(k) Report

FDA applicant

Vygon Us, LLC

Norristown, PA3 decisions2004–20060 recalls

FDA records 3 decisions for Vygon Us, LLC (Norristown, PA) from 2004 to 2006: 3 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and LJS (Catheter, Intravascular, Therapeutic…). 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, general hospital panel, where it files most

How often FDA has decided Vygon Us, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vygon Us, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Vygon”

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