HWX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tap, Bone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 91 · 2022: 91 · 2023: 84 · 2024: 84 · 2025: 103 · 2026: 114
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 |
|---|---|---|
| ACROMED BONE SCREW TAP SLEEVES (K873067) | Buckman Co., Inc. | 1987-09-02 |
| FEMORAL CEMENT REMOVAL INSTRUMENT (K840735) | Amtech Scientific, Inc. | 1984-05-14 |
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Every clearance here is in the API, with alerts when new ones post.