HWA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Impactor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 2,006 · 2022: 2,086 · 2023: 2,237 · 2024: 2,008 · 2025: 1,939 · 2026: 1,235
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 |
|---|---|---|
| MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (K933527) | Mira, Inc. | 1994-01-25 |
| RAYLOR(TM) MALLET (K864422) | Cedar Surgical, Inc. | 1986-11-24 |
| MALLET (K841627) | Plastafil, Inc. | 1984-08-27 |
| CEMENT CHISELS (K770205) | Depuy, Inc. | 1977-02-08 |
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Every clearance here is in the API, with alerts when new ones post.