FDA applicant

Goodmark USA, Inc.

Southborough, MA1 decision2005–20050 recalls

FDA records 1 decision for Goodmark USA, Inc. (Southborough, MA) in 2005: 1 510(k) clearance. All are in product code NUC (Lubricant, Personal). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Goodmark USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Goodmark USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Goodmark USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?