FDA applicant

Wiltek Medical, Inc.

Winston-Salem, NC21 decisions1989–19990 recalls

FDA records 21 decisions for Wiltek Medical, Inc. (Winston-Salem, NC) from 1989 to 1999: 21 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and GEI (Electrosurgical, Cutting & Coagulation &…). 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 Wiltek Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wiltek Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Wiltek Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?