FDA applicant

Epicor Medical, Inc.

Sunnyvale, CA2 decisions2004–20040 recalls

FDA records 2 decisions for Epicor Medical, Inc. (Sunnyvale, CA) in 2004: 2 510(k) clearances. All are in product code NTB (System, Ablation, Ultrasound And Accessories). Its devices cite 16 predicates, 1 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Epicor Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Epicor Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?