OXH
5 FDA 510(k) clearances · Product code
90 daysmedian time to decision
250 days90th percentile
5clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
- Adverse events (MAUDE)
- 2016: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Kerecis SurgiBind (50241) (K251844) | Kerecis Limited | 2025-07-15 |
| Kerecis Reconstruct (K202430) | Kerecis Limited | 2021-05-02 |
| SurgiMend PRS Meshed, Revize-X (K171357) | Integra Lifesciences Corporation (Owner of Tei Biosciences) | 2017-06-07 |
| Miromatrix Biological Mesh (K160400) | Miromatrix Medical, Inc. | 2016-06-08 |
| Miromatrix Biological Mesh RS (K150341) | Miromatrix Medical, Inc. | 2015-05-12 |
Track OXH automatically
Every clearance here is in the API, with alerts when new ones post.