FDA applicant

Ela Medical, Inc.

Minnetonka, MN43 decisions1979–20040 recalls

FDA records 43 decisions for Ela Medical, Inc. (Minnetonka, MN) from 1979 to 2004: 43 510(k) clearances. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and DTB (Permanent Pacemaker Electrode). Its devices cite 26 predicates, 11 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, cardiovascular panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Ela 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?