FDA applicant

Cardio-Pace Medical, Inc.

St. Paul, MN3 decisions1985–19870 recalls

FDA records 3 decisions for Cardio-Pace Medical, Inc. (St. Paul, MN) from 1985 to 1987: 3 510(k) clearances. All are in product code DXY (Implantable Pacemaker Pulse-Generator). 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 Cardio-Pace Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio-Pace Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardio-Pace Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Cardio-Pace Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?