510(k) Report

FDA applicant

Medical and Scientific Enterprises, Inc.

Concord, MA5 decisions1987–19940 recalls

FDA records 5 decisions for Medical and Scientific Enterprises, Inc. (Concord, MA) from 1987 to 1994: 5 510(k) clearances. Most are in product codes KNS (Unit, Electrosurgical, Endoscopic (With Or…) and KGI (Densitometer, Bone). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Medical and Scientific Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical and Scientific Enterprises, 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?

  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2decisions
  • KGIDensitometer, Bone1decision
  • IYWScanner, Rectilinear, Nuclear1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

What has FDA decided for it lately?

  • K933131Bistat 70/70-I Electrosurgical UnitMedical and Scientific Enterprises, Inc. · 1994
  • K913881Endostat Electrosurgical UnitMedical and Scientific Enterprises, Inc. · 1991
  • K895855PhoenixMedical and Scientific Enterprises, Inc. · 1990
  • K882453Polyscan Digital ScannerMedical and Scientific Enterprises, Inc. · 1988
  • K861233Dual Photon Bone DensitometerMedical and Scientific Enterprises, Inc. · 1987

All 5 as Medical and Scientific Enterprises, Inc. →