HXX
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Screwdriver
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 2,001 · 2022: 1,721 · 2023: 1,733 · 2024: 1,708 · 2025: 2,151 · 2026: 1,072
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 |
|---|---|---|
| DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER (K901166) | Dalton Technology, Inc. | 1990-06-13 |
| ACROMED SCREW DRIVER (K873066) | Buckman Co., Inc. | 1987-09-02 |
| PRECISION SCREW DRIVER SET (K872389) | Med-Tool, Inc. | 1987-07-15 |
| 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP (K862689) | W. L. Gore & Associates, Inc. | 1986-09-02 |
Track HXX automatically
Every clearance here is in the API, with alerts when new ones post.