510(k) Report

FDA applicant

Biover AG

Ridley Park, PA1 decision2002–20020 recalls

FDA records 1 decision for Biover AG (Ridley Park, PA) in 2002: 1 510(k) clearance. All are in product code DXC (Clamp, Vascular). 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 Biover AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biover AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biover AG 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?

  • DXCClamp, Vascular1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K011208BioverBiover AG · 20021cites it

What has FDA decided for it lately?

The one decision as Biover AG →