FNW
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pad, Kelly
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1996: 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 |
|---|---|---|
| MICROMAT W/VARIOUS MODELS (K831117) | Pmt, Inc. | 1984-05-30 |
| SODIUM CHLORIDE SOLUTION BLOOD CELL (K841183) | Reagent Laboratory, Inc. | 1984-05-21 |
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Every clearance here is in the API, with alerts when new ones post.