FDA applicant

Cardia Concepts Corp.

Mchenry, IL3 decisions1980–19800 recalls

FDA records 3 decisions for Cardia Concepts Corp. (Mchenry, IL) in 1980: 3 510(k) clearances. All are in product code DRM (Compressor, Cardiac, External). 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 Cardia Concepts Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardia Concepts Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Cardia”

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

Cardia Innovation AB 2

Cardia Concepts Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Cardia”