FDA applicant

Primrose Medical, Inc.

Woburn, MA14 decisions1984–19890 recalls

FDA records 14 decisions for Primrose Medical, Inc. (Woburn, MA) from 1984 to 1989: 14 510(k) clearances. Most are in product codes KNQ (Dilator, Esophageal) and KNT (Tubes, Gastrointestinal (And Accessories)). 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 Primrose Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Primrose Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?