FDA applicant

Cardiomems, Inc.

Atlanta, GA5 decisions2005–20080 recalls

FDA records 5 decisions for Cardiomems, Inc. (Atlanta, GA) from 2005 to 2008: 4 510(k) clearances and 1 De Novo grant. All are in product code NQH (Sensor, Pressure, Aneurysm, Implantable). 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 Cardiomems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Cardiomems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?