DWI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Saw, Electrically Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2000: 1 · 2001: 1 · 2002: 1 · 2004: 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 |
|---|---|---|
| STRYKER ECLIPSE WARMING STRETCHER (K912237) | Stryker Medical | 1991-07-30 |
| TEMP STERNUM SAW (K801914) | Temp Medical Products, Inc. | 1980-10-23 |
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