HXI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Passer, Wire, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2011: 10 · 2012: 9 · 2013: 7 · 2016: 35 · 2018: 13 · 2026: 27
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 |
|---|---|---|
| Y WIRE 2 (K140576) | Safewire, LLC | 2014-05-20 |
| BOWEN KNOT PASSER (K863148) | Bowen & Company, Inc. | 1986-09-05 |
| BOWEN SUTURE PASSER (K863146) | Bowen & Company, Inc. | 1986-09-05 |
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Every clearance here is in the API, with alerts when new ones post.