On-X Life Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2133-2026 | Class II | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 | February 1, 2026 |
| Z-1057-2017 | Class II | Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement | December 13, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141060 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | June 6, 2014 |