FDA applicant

Cardiotronics, Inc.

West Carlsbad, CA27 decisions1988–19950 recalls

FDA records 27 decisions for Cardiotronics, Inc. (West Carlsbad, CA) from 1988 to 1995: 27 510(k) clearances. Most are in product codes LDD (Dc-Defibrillator, Low-Energy, (Including…) and DRO (Pacemaker, Cardiac, External Transcutaneous…). 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 Cardiotronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiotronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Cardiotronics”

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

Cardiotronics Systems, Inc. 4

Cardiotronics, Inc.

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 “Cardiotronics”