Data / Medical devices / Absorbable Synthetic Wound Dressing
Absorbable Synthetic Wound Dressing (QSZ): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Absorbable Synthetic Wound Dressing (product code QSZ, Class U). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on October 16, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QSZ
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| China | 2 |
| Australia | 1 |
| Germany | 1 |
Makers of Absorbable Synthetic Wound Dressing
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Polynovo Biomaterials Pty Ltd | Port Melbourne Victoria, Australia | Complaint file establishment, Manufacturer | 3 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Anika Therapeutics, Inc. | Bedford, MA, United States | Complaint file establishment, Manufacturer | 2 | September 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Acera Surgical, Inc. C/O Linda Braddon, PhD | Woodstock, GA, United States | Complaint file establishment, Specification developer | 2 | September 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Polymedics Innovations | Kirchheim unter Teck Baden-Wurttemberg, Germany | Manufacturer | 2 | June 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Acera Surgical - Adie Road | Maryland Heights, MO, United States | Manufacturer | 1 | May 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Beijing Kreate Medical Co., Ltd. | Beijing, China | Manufacturer | 1 | April 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ets Wound Care LLC | Rolla, MO, United States | Manufacturer | 1 | September 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Huizhou Foryou Medical Devices Co.,ltd. | HuiZhou Guangdong, China | Manufacturer | 1 | August 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nanofiber Solutions LLC | Dublin, OH, United States | Manufacturer | 1 | March 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| SiOxMed, LLC | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 1 | July 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Poly-Med, Inc. | Piedmont, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.