HXW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bender
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2018: 43 · 2019: 24 · 2020: 16 · 2024: 25 · 2025: 30 · 2026: 29
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 PLATE BENDER (K872949) | Buckman Co., Inc. | 1987-10-15 |
| DRIVER-BENDER-EXTRACTOR, BONE PIN (K870668) | Military Engineering, Inc. | 1987-03-09 |
| RD 140 SURGICAL BENDER (K870084) | Terray Manufacturing, Inc. | 1987-01-28 |
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Every clearance here is in the API, with alerts when new ones post.