FDA applicant

Vygon USA

Lansdale Montgomery, PA4 decisions2018–20241 recall

FDA records 4 decisions for Vygon USA (Lansdale Montgomery, PA) from 2018 to 2024: 4 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and FPD (Tube, Feeding). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2019

2018high 1 (2019) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Vygon USA by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vygon USA’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 “Vygon”

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

Vygon Corp. 53 Vygon Us, LLC 3 Vygon Neuro 1

Vygon USA

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 “Vygon”