Company · AU
Polynovo Biomaterials Pty, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2025 | K251567 | NovoSorb BTM Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| Mar 5, 2025 | K242149 | NovoSorb® MTX Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| Sep 15, 2022 | K221686 | NovoSorb Matrix Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| Aug 11, 2017 | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| Dec 23, 2015 | K142879 | BTM Wound Dressing Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| Mar 4, 2014 | K132936 | NOVOPORE DRESSING Polynovo Biomaterials Pty, Ltd. | OMP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||