FDA applicant

Polynovo Biomaterials Pty, Ltd.

Port Melbourne, AU6 decisions2014–20250 recalls

FDA records 6 decisions for Polynovo Biomaterials Pty, Ltd. (Port Melbourne, AU) from 2014 to 2025: 6 510(k) clearances. Most are in product codes QSZ (Absorbable Synthetic Wound Dressing) and OMP (Negative Pressure Wound Therapy Powered…). Its devices cite 8 predicates, 4 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, general and plastic surgery panel, where it files most

How often FDA has decided Polynovo Biomaterials Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2014high 2 (2025) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Polynovo Biomaterials Pty, Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Polynovo Biomaterials Pty, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?