Change Healthcare Israel Ltd.

FDA Regulatory Profile

Change Healthcare Israel Ltd. appears in FDA public data with 2 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1490-2019, Class II) was initiated on March 25, 2019. Its most recent 510(k) clearance was granted on September 11, 2023.

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1490-2019Class IIMcKesson Cardiology HemoMarch 25, 2019
Z-1489-2019Class IIHorizon Cardiology HemoMarch 25, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K230881Change Healthcare Cardiology Hemodynamics™September 11, 2023
K212528Change Healthcare CardiologyOctober 18, 2021
K181080McKesson CardiologyMay 24, 2018