510(k) Report

FDA applicant

Hardwood Products Co., LP

Guilford, ME1 decision1996–19960 recalls

FDA records 1 decision for Hardwood Products Co., LP (Guilford, ME) in 1996: 1 510(k) clearance. All are in product code HHT (Spatula, Cervical, Cytological). 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 Hardwood Products Co., LP’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hardwood Products Co., LP since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HHTSpatula, Cervical, Cytological1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K961934Puritan Foam Tip Swab Model 2197Hardwood Products Co., LP · 19961cites it

What has FDA decided for it lately?

  • K961934Puritan Foam Tip Swab Model 2197Hardwood Products Co., LP · 1996

The one decision as Hardwood Products Co., LP →

Other applicant names beginning “Hardwood”

FDA records each applicant name separately; these may or may not be the same firm.

Hardwood Design Shop 1