FDA applicant

Poly-Medics,Inc.

Warsaw, IN5 decisions1994–19961 recall

FDA records 5 decisions for Poly-Medics,Inc. (Warsaw, IN) from 1994 to 1996: 5 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and HRS (Plate, Fixation, Bone). 1 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, orthopedic panel, where it files most

How often FDA has decided Poly-Medics,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Poly-Medics,Inc. since 2007.

Recalls per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Poly-Medics,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 “Poly-Medics”

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

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

Poly-Medics,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?

What has been recalled?

Other applicant names beginning “Poly-Medics”