Mimedx Group, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mimedx Group, Inc.” (first 2010, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 62 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMR | Vessel Guard Or Cover | 4 | 4 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
Review panels
Most recent Mimedx Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100313 | HYDROFIX SURGICAL SHEET | FTL | 2011-06-14 | 495 |
| K111137 | HYDROFIX VASO SHIELD | OMR | 2011-05-20 | 28 |
| K101805 | HYDROFIX VASO SHIELD | OMR | 2011-04-08 | 284 |
| K101826 | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | OMR | 2010-07-28 | 27 |
| K100905 | HYDROFIX SURGICAL SHEET | OMR | 2010-06-02 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Mimedx Group, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Mimedx Group, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06236750: Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds (Recruiting, started 2023-08-04)
- NCT01921491: DHACM vs Other Commercially Available Treatments (Completed, started 2013-08)
SEC filings
MIMEDX GROUP, INC. (MDXG): EDGAR filings, CIK 1376339. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mimedx Group, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Mimedx Group, Inc.” (first 2010, latest 2011), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mimedx Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mimedx Group, Inc. is 62 days.
Which FDA product codes appear under Mimedx Group, Inc.?
The most frequent FDA product codes under this applicant name are OMR (Vessel Guard Or Cover, 4); FTL (Mesh, Surgical, Polymeric, 1).
Next steps
- See all 5 Mimedx Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OMR, Mimedx Group, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.