510(k) Report

FDA applicant

Scientific Medical Devices, Inc.

Cumming, GA1 decision1995–19950 recalls

FDA records 1 decision for Scientific Medical Devices, Inc. (Cumming, GA) in 1995: 1 510(k) clearance. All are in product code GXY (Electrode, Cutaneous). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Scientific Medical Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scientific Medical Devices, Inc. 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?

  • GXYElectrode, Cutaneous1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K943009SMD ElectrodesScientific Medical Devices, Inc. · 19952cite it

What has FDA decided for it lately?

  • K943009SMD ElectrodesScientific Medical Devices, Inc. · 1995

The one decision as Scientific Medical Devices, Inc. →