NXM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Eyelid Spacer/Graft, Biologic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3130
- Medical specialty
- Ophthalmic
- Flags
- Implant
- FDA definition
- For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT (K090078) | Iop, Inc. | 2009-05-08 |
| SURGISIS OCULAR GRAFT (K053622) | Iop, Inc. | 2006-03-15 |
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Every clearance here is in the API, with alerts when new ones post.