FDA applicant

Cardiobiomedical Corporation

Natick, MA1 decision2005–20050 recalls

FDA records 1 decision for Cardiobiomedical Corporation (Natick, MA) in 2005: 1 510(k) clearance. All are in product code DQK (Computer, Diagnostic, Programmable). 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 Cardiobiomedical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiobiomedical Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Cardiobiomedical Corporation

Which product codes does it file in?

What has FDA decided for it lately?