510(k) Report

FDA applicant

Burdick Corp.

Mchenry, IL44 decisions1976–19960 recalls

FDA records 44 decisions for Burdick Corp. (Mchenry, IL) from 1976 to 1996: 44 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). No recall is linked to its devices.

FDA’s records also spell it “Burdick, Inc.”.

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 Burdick Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Burdick Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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