FDA applicant

General Cardiac Technology, Inc.

Sunnyvale, CA1 decision1988–19880 recalls

FDA records 1 decision for General Cardiac Technology, Inc. (Sunnyvale, CA) in 1988: 1 510(k) clearance. All are in product code KMO (Binder, Elastic). 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, general hospital panel, where it files most

How often FDA has decided General Cardiac Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for General Cardiac Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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General Cardiac Technology, Inc.

Which product codes does it file in?

What has FDA decided for it lately?