GDR
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Saw, Manual And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1995: 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 |
|---|---|---|
| BONE CUTTING INSTRUMENTS & ACCESSORIES (K874961) | Solway, Inc. | 1987-12-30 |
| 27-100 TO 29-130 VARIOUS BONE SAWS-CHARRIERE, SATT (K851787) | Artiberia | 1985-06-20 |
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Every clearance here is in the API, with alerts when new ones post.