NFM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Expander, Tissue, Orbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Medical specialty
- Ophthalmic
- Flags
- Implant
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ORBITAL TISSUE EXPANDER (OTE) (K060151) | Innovia, LLC | 2006-08-08 |
| OSMED TISSUE EXPANDER (K010852) | Iop, Inc. | 2001-08-13 |
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Every clearance here is in the API, with alerts when new ones post.