FDA applicant

Polymedica Healthcare, Inc.

Golden,, CO1 decision1993–19930 recalls

FDA records 1 decision for Polymedica Healthcare, Inc. (Golden,, CO) in 1993: 1 510(k) clearance. All are in product code 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 Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Polymedica Healthcare, 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 Industries, Inc. 16 Polymedica Pharmaceuticals, U.S.A., Inc.] 1

Polymedica Healthcare, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Polymedica”