Data / Medical devices / United States / Polymedics Innovations, Inc.
Polymedics Innovations, Inc.: FDA-registered device maker in Woodstock, GA, United States, 2 510(k) clearances
Polymedics Innovations, Inc. is registered with the FDA (registration 3012366156) in Woodstock, GA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012366156
- Address
- 645 Molly Lane Suite 100, Woodstock, GA, United States, 30189
- Owner or operator
- Polymedics Innovations (10029744)
- Roles
- Complaint file establishment
- First device listed
- June 22, 2009
- Registered through
- 2026
- Brand names listed
- SupraSDRM, Suprathel CW, Suprathel Hand, Suprathel Wound and Burn Dressing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | U | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 28, 2017 | K170213 | SupraSDRM Biodegradable Matrix Wound Dressing | QSZ | Substantially Equivalent | Polymedics Innovations, GmbH | accessdata.fda.gov |
| May 20, 2009 | K090160 | SUPRATHEL WOUND AND BURN DRESSING | QSZ | Substantially Equivalent | Polymedics Innovations, GmbH | accessdata.fda.gov |
Compare with other makers
Updated June 28, 2017. 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.