510(k) Report

FDA applicant

Veryan Medical Limited

Gambrills, MD3 decisions2005–20180 recalls

FDA records 3 decisions for Veryan Medical Limited (Gambrills, MD) from 2005 to 2018: 2 510(k) clearances and 1 original PMA approval. Most are in product codes DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…) and NIP (Stent, Superficial Femoral Artery). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Veryan Medical, Ltd.”.

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 Veryan Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2decisions
  • NIPStent, Superficial Femoral Artery1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051312Swirlgraft Bypass and Vascular Access GraftsVeryan Medical Limited · 20052cite it
  • K060741Swirlgraft Vascular Access GraftVeryan Medical Limited · 20061cites it

What has FDA decided for it lately?

  • P180003BioMimics 3D Vascular Stent SystemVeryan Medical, Ltd. · 2018
  • K060741Swirlgraft Vascular Access GraftVeryan Medical Limited · 2006
  • K051312Swirlgraft Bypass and Vascular Access GraftsVeryan Medical Limited · 2005

All 2 as Veryan Medical Limited →The one decision as Veryan Medical, Ltd. →