510(k) Report

FDA applicant

Bard Electrophysiology

Lowell, MA3 decisions1989–20040 recalls

FDA records 3 decisions for Bard Electrophysiology (Lowell, MA) from 1989 to 2004: 3 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and DRQ (Amplifier And Signal Conditioner, Transducer…). 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 Electrophysiology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bard Electrophysiology since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bard Electrophysiology 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.