HWM
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Osteotome
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 73 · 2022: 75 · 2023: 72 · 2024: 93 · 2025: 54 · 2026: 81
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 |
|---|---|---|
| MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER (K874503) | Micro-Aire Surgical Instruments, Inc. | 1987-12-02 |
| ACROMED WALLIE-HEINIG OSTEOTOMES (K870780) | Buckman Co., Inc. | 1987-03-09 |
| OSTEOTOMES FOR CUTTING BONH (K771744) | Depuy, Inc. | 1977-09-28 |
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Every clearance here is in the API, with alerts when new ones post.