FDA applicant

Facile Medical, Inc.

Mission Viejo, CA1 decision2005–20050 recalls

FDA records 1 decision for Facile Medical, Inc. (Mission Viejo, CA) in 2005: 1 510(k) clearance. 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 Facile Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Facile Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Facile Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?