Product code QSZ · Class U
Absorbable Synthetic Wound Dressing
4510(k)s in 12 months (22 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QSZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Polynovo Biomaterials Pty, Ltd. | 5 | 0 |
| Acera Surgical, Inc. | 4 | 0 |
| Sioxmed, LLC | 3 | 0 |
| Polymedics Innovations, GmbH | 2 | 0 |
| Anika Therapeutics, Inc. | 1 | 0 |
| Beijing Kreate Medical Co., Ltd. | 1 | 0 |
| Biomet Merck GmbH | 1 | 0 |
| Engineered Tissue Solutions, LLC | 1 | 0 |
| Fidia Advanced Biopolymers Srl | 1 | 0 |
| Huizhou Foryou Medical Devices Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K261245 | Restrata Acera Surgical, Inc. | QSZ |
| Sep 2, 2026 | K261311 | HYALOMATRIX Anika Therapeutics, Inc. | QSZ |
| Aug 18, 2026 | K254256 | LUOFUCON® Wound Matrix Huizhou Foryou Medical Devices Co., Ltd., CN | QSZ |
| Apr 16, 2026 | K260020 | Redermo Wound Matrix Beijing Kreate Medical Co., Ltd., CN | QSZ |
| Jun 20, 2025 | K251567 | NovoSorb BTM Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| Mar 5, 2025 | K242149 | NovoSorb® MTX Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| Jul 5, 2024 | K241660 | SiOxD® Wound Matrix Sioxmed, LLC | QSZ |
| Dec 18, 2023 | K232847 | SiOxD Wound Matrix Sioxmed, LLC | QSZ |
| May 18, 2023 | K223725 | Restrata® MiniMatrix Acera Surgical, Inc. | QSZ |
| Nov 18, 2022 | K222189 | SiOxD Wound Matrix Sioxmed, LLC | QSZ |
| Sep 15, 2022 | K221686 | NovoSorb Matrix Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| Sep 25, 2020 | K193583 | Restrata® Acera Surgical, Inc. | QSZ |
| Mar 2, 2018 | K173544 | Phoenix Wound Matrix Nanofiber Solutions, Inc. | 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 |
| Jun 28, 2017 | K170213 | SupraSDRM Biodegradable Matrix Wound Dressing Polymedics Innovations, GmbH, DE | QSZ |
| Apr 26, 2017 | K170300 | Restrata Wound Matrix Acera Surgical, Inc. | QSZ |
| Sep 15, 2016 | K161067 | Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen Advanced Wound Matrix, 1x6 Engineered Tissue Solutions, LLC | QSZ |
| Dec 23, 2015 | K142879 | BTM Wound Dressing Polynovo Biomaterials Pty, Ltd., AU | QSZ |
| May 7, 2014 | K132397 | GORE BIO-A WOUND MATRIX W. L. Gore & Associates, Inc. | QSZ |
| May 20, 2009 | K090160 | SUPRATHEL WOUND AND BURN DRESSING Polymedics Innovations, GmbH, DE | QSZ |
| Dec 14, 2007 | K073251 | HYALOMATRIX PA Fidia Advanced Biopolymers Srl | QSZ |
| Oct 30, 2003 | K031684 | TOPKIN WOUND DRESSING Biomet Merck GmbH, CH | QSZ |
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