FDA applicant

A-Med Systems, Inc.

West Sacramento, CA4 decisions1999–20020 recalls

FDA records 4 decisions for A-Med Systems, Inc. (West Sacramento, CA) from 1999 to 2002: 4 510(k) clearances. Most are in product codes KFM (Pump, Blood, Cardiopulmonary Bypass…) and DWF (Catheter, Cannula And Tubing, Vascular…). Its devices cite 9 predicates, 2 of them its own earlier devices. 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 A-Med Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for A-Med Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — A-Med Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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A-Med Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?