FXF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Speculum, Illuminated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.1800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1993: 1 · 1997: 1
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 |
|---|---|---|
| ILLUMINATED SPECULUM (K801058) | Designs For Vision, Inc. | 1980-05-28 |
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Every clearance here is in the API, with alerts when new ones post.