FDA applicant

Bard Cardiosurgery Div

Billerica, MA3 decisions1989–19920 recalls

FDA records 3 decisions for Bard Cardiosurgery Div (Billerica, MA) from 1989 to 1992: 3 510(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 Bard Cardiosurgery Div’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bard Cardiosurgery Div since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Bard”

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

Bard Peripheral Vascular, Inc. 46 Bard Access Systems, Inc. 22 Bard Diagnostic Sciences,Inc. 3 Bard Medical Div. 3 Bard Access Systems, Inc. (C.R. Bard, Inc.) 3 Bard Electrophysiology 3 Bard Interventional Products Div. 2 Bard Access Systems, Inc. (Bard Has Joined Bd) 2 Bard Peripheral Vacular, Inc. 1 Bard Reproductive Systems 1 Bard Gynecology and Radiology 1 Bard Electro Medical Systems, Inc. 1

Bard Cardiosurgery Div

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bard”