Data / Medical devices / United States / Reprise Biomedical, Inc.
Reprise Biomedical, Inc.: FDA-registered device maker in Plymouth, MN, United States, 7 510(k) clearances
Reprise Biomedical, Inc. is registered with the FDA (registration 3010894343) in Plymouth, MN, United States. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010894343
- Address
- 17400 Medina Road Suite 100, Plymouth, MN, United States, 55447
- Owner or operator
- Reprise Biomedical (10078738)
- Roles
- Manufacturer
- First device listed
- November 3, 2020
- Registered through
- 2026
- Brand names listed
- Miro3D Fibers Wound Matrix, Miro3D Wound Matrix, MiroDerm Fenestrated, MiroDerm Fenestrated Plus, MiroDry Wound Matrix, MiroFlex Biologic Matrix, MiroTract Wound Matrix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 19, 2024 | K240753 | Miro3D Fibers Wound Matrix | KGN | Substantially Equivalent | Reprise Biomedical, Inc. | accessdata.fda.gov |
| March 1, 2024 | K240277 | MiroDry Wound Matrix | KGN | Substantially Equivalent | Reprise Biomedical, Inc. | accessdata.fda.gov |
| December 13, 2023 | K231614 | MiroTract Wound Matrix | KGN | Substantially Equivalent | Reprise Biomedical, Inc. | accessdata.fda.gov |
| November 21, 2022 | K223257 | Miro3D Wound Matrix | KGN | Substantially Equivalent | Reprise Biomedical | accessdata.fda.gov |
| August 18, 2022 | K221520 | Miro3D Wound Matrix | KGN | Substantially Equivalent | Reprise Biomedical, Inc. | accessdata.fda.gov |
| January 27, 2015 | K143426 | Wound Matrix TF | KGN | Substantially Equivalent | Miromatrix Medical, Inc. | accessdata.fda.gov |
| March 31, 2014 | K134033 | MIROMATRIX BIOLOGICAL MESH | FTM | Substantially Equivalent | Miromatrix Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 19, 2024. 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.