FDA applicant

Polymedica Pharmaceuticals, U.S.A., Inc.]

Woburn, MA1 decision2002–20020 recalls

FDA records 1 decision for Polymedica Pharmaceuticals, U.S.A., Inc.] (Woburn, MA) in 2002: 1 510(k) clearance. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, clinical chemistry panel, where it files most

How often FDA has decided Polymedica Pharmaceuticals, U.S.A., Inc.]’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polymedica Pharmaceuticals, U.S.A., Inc.] since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Polymedica Pharmaceuticals, U.S.A., Inc.] by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Polymedica Pharmaceuticals, U.S.A.…’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 “Polymedica”

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

Polymedica Industries, Inc. 16 Polymedica Healthcare, Inc. 1

Polymedica Pharmaceuticals, U.S.A., Inc.]

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Polymedica”