Panels › General, Plastic Surgery › Product code OXH · Class 2
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Regulation 878.3300
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OXH
| Company | 510(k)s | Recalls |
|---|---|---|
| Kerecis Limited | 2 | 0 |
| Miromatrix Medical, Inc. | 2 | 0 |
| Integra Lifesciences Corporation (Owner of Tei Biosciences) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2025 | K251844 | Kerecis SurgiBind (50241) Kerecis Limited, IS | OXH |
| May 2, 2021 | K202430 | Kerecis Reconstruct Kerecis Limited, IS | OXH |
| Jun 7, 2017 | K171357 | SurgiMend PRS Meshed, Revize-X Integra Lifesciences Corporation (Owner of Tei Biosciences) | OXH |
| Jun 8, 2016 | K160400 | Miromatrix Biological Mesh Miromatrix Medical, Inc. | OXH |
| May 12, 2015 | K150341 | Miromatrix Biological Mesh RS Miromatrix Medical, Inc. | OXH |
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