FDA applicant

Puritan Medical Products, LLC

Guilford, ME8 decisions2012–20250 recalls

FDA records 8 decisions for Puritan Medical Products, LLC (Guilford, ME) from 2012 to 2025: 8 510(k) clearances. Most are in product codes JSM (Culture Media, Non-Propagating Transport) and LIO (Device, Specimen Collection). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Puritan Medical Products Company, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Puritan Medical Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012high 3 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Puritan Medical Products, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Puritan Medical Products, LLC’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

Other applicant names beginning “Puritan”

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

Puritan Bennett Corp. 114 Puritan-Bennett Ireland, Ltd. 1

Puritan Medical Products, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Puritan”