FDA applicant

American Bentley

Irvine, CA59 decisions1983–19880 recalls

FDA records 59 decisions for American Bentley (Irvine, CA) from 1983 to 1988: 59 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and DTN (Reservoir, Blood, Cardiopulmonary Bypass). 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 American Bentley’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Bentley since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Bentley

Which product codes does it file in?

What has FDA decided for it lately?