FDA applicant

Polymedica Industries, Inc.

Golden,, CO16 decisions1993–19970 recalls

FDA records 16 decisions for Polymedica Industries, Inc. (Golden,, CO) from 1993 to 1997: 16 510(k) clearances. Most are in product codes MGP (Dressing, Wound And Burn, Occlusive) and FLL (Continuous Measurement Thermometer). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Polymedica Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Polymedica”

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

Polymedica Pharmaceuticals, U.S.A., Inc.] 1 Polymedica Healthcare, Inc. 1

Polymedica Industries, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Polymedica”