On-X Life Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1057-2017Class IIChord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement December 13, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K141060CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENTJune 6, 2014