FDA applicant

Poly-Med Splint Co.

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Poly-Med Splint Co. (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code DRX (Electrode, Electrocardiograph). 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, cardiovascular panel, where it files most

How often FDA has decided Poly-Med Splint Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Poly-Med Splint Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Poly-Med Splint Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Poly-Med Splint Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Poly-Med”

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

Poly Medicure Limited 7 Poly-Medics,Inc. 5 Poly Vue Technolgies, Inc. 2 Poly Shield Industries (Malaysia) Sdn. Bhd. 1 The Poly Group, Inc. 1 Poly-Tech Medical Device Research & Development 1 Poly- Med, Inc. 1 Poly Medical Technologies, Inc. 1

Poly-Med Splint Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Poly-Med”