FDA applicant

C.R. Bard Inc., Bard Electrophysiology Division

Lowell, MA3 decisions2008–20120 recalls

FDA records 3 decisions for C.R. Bard Inc., Bard Electrophysiology Division (Lowell, MA) from 2008 to 2012: 3 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DQX (Wire, Guide, Catheter). Its devices cite 7 predicates, 1 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 C.R. Bard Inc., Bard Electrophysiology Division’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — C.R. Bard Inc., Bard Electrophysiology Division by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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C.R. Bard Inc., Bard Electrophysiology Division

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?