FDA applicant

Cardiotronics Systems, Inc.

Carlsbad, CA4 decisions1996–19974 recalls

FDA records 4 decisions for Cardiotronics Systems, Inc. (Carlsbad, CA) from 1996 to 1997: 4 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). 4 recalls are linked to its devices, 2 Class I.

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 Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiotronics Systems, Inc. since 2007.

Recalls per year

2in 2014

2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardiotronics Systems, 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, Inc. 27

Cardiotronics Systems, 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?

What has been recalled?

Other applicant names beginning “Cardiotronics”