FZO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Chisel, Surgical, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2020: 17 · 2021: 28 · 2022: 18 · 2023: 21 · 2024: 19 · 2025: 27
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 |
|---|---|---|
| 29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES, (K851788) | Artiberia | 1985-06-20 |
| JAKOBI SURG. INSTRUMENTS #12 40/41 (K834198) | Imm Enterprises , Ltd. | 1984-01-27 |
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Every clearance here is in the API, with alerts when new ones post.