FDA applicant

Ep Dynamics, Inc.

Mission Viejo, CA2 decisions2009–20120 recalls

FDA records 2 decisions for Ep Dynamics, Inc. (Mission Viejo, CA) from 2009 to 2012: 2 510(k) clearances. All are in product code DYB (Introducer, Catheter). 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 Ep Dynamics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Ep Dynamics, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Ep Dynamics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?