FDA applicant

Portlyn Corp.

Moultonboro, NH8 decisions1990–19970 recalls

FDA records 8 decisions for Portlyn Corp. (Moultonboro, NH) from 1990 to 1997: 8 510(k) clearances. Most are in product codes FCL (Forceps, Biopsy, Non-Electric) and DWZ (Device, Biopsy, Endomyocardial). 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 Portlyn Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Portlyn Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Portlyn Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Portlyn Corp.

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?