510(k) Report

FDA applicant

Med-Edge, Inc.

Clemmons, NC2 decisions1988–19980 recalls

FDA records 2 decisions for Med-Edge, Inc. (Clemmons, NC) from 1988 to 1998: 2 510(k) clearances. Most are in product codes KPK (Marker, Ostia, Aorto-Saphenous Vein) and DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). 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, general and plastic surgery panel, where it files most

How often FDA has decided Med-Edge, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med-Edge, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Med-Edge, 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?

  • KPKMarker, Ostia, Aorto-Saphenous Vein1decision
  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter1decision

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.

  • K971966Coronary Vein Graft Tag MarkerMed-Edge, Inc. · 19981cites it

What has FDA decided for it lately?

  • K971966Coronary Vein Graft Tag MarkerMed-Edge, Inc. · 1998
  • K882314Coronary Vein Graft MarkerMed-Edge, Inc. · 1988

All 2 as Med-Edge, Inc. →