510(k) Report

FDA applicant

Emd Electronic Medical Devices, Corp.

Miami Beach, FL1 decision2001–20010 recalls

FDA records 1 decision for Emd Electronic Medical Devices, Corp. (Miami Beach, FL) in 2001: 1 510(k) clearance. All are in product code KPI (Stimulator, Electrical, Non-Implantable, For…). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Emd Electronic Medical Devices, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Emd Electronic Medical Devices, Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KPIStimulator, Electrical, Non-Implantable, For Incontinence1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K002154K.E.A.T.Emd Electronic Medical Devices, Corp. · 20011cites it

What has FDA decided for it lately?

  • K002154K.E.A.T.Emd Electronic Medical Devices, Corp. · 2001

The one decision as Emd Electronic Medical Devices, Corp. →