FDA applicant

Giltech Plus, Inc.

Milford, PA3 decisions1999–19990 recalls

FDA records 3 decisions for Giltech Plus, Inc. (Milford, PA) in 1999: 3 510(k) clearances. Most are in product codes KDH (Catheter (Gastric, Colonic, Etc.), Irrigation…) and NAE (Dressing, Wound, Hydrogel Without Drug And/Or…). 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 Giltech Plus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Giltech Plus, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Giltech Plus, Inc.

Which product codes does it file in?

What has FDA decided for it lately?