510(k) Report

FDA applicant

Maryrose Cusimano, Ph.D. & Scott Zeff

Ft. Lauderdale, FL1 decision2000–20000 recalls

FDA records 1 decision for Maryrose Cusimano, Ph.D. & Scott Zeff (Ft. Lauderdale, FL) in 2000: 1 510(k) clearance. All are in product code IKN (Electromyograph, Diagnostic). 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, physical medicine panel, where it files most

How often FDA has decided Maryrose Cusimano, Ph.D. & Scott Zeff’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Maryrose Cusimano, Ph.D. & Scott Zeff since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Maryrose Cusimano, Ph.D. & Scott Zeff 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?

  • IKNElectromyograph, Diagnostic1decision

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.

  • K002104Combined Physiological Monitoring SystemMaryrose Cusimano, Ph.D. & Scott Zeff · 20002cite it

What has FDA decided for it lately?

  • K002104Combined Physiological Monitoring SystemMaryrose Cusimano, Ph.D. & Scott Zeff · 2000

The one decision as Maryrose Cusimano, Ph.D. & Scott Zeff →

Other applicant names beginning “Maryrose”

FDA records each applicant name separately; these may or may not be the same firm.

Maryrose Cusimano, Ph.D./Phil Reaston 1Maryrose 1