McKesson Israel Ltd.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2968-2018Class IIMcKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and datMarch 12, 2018
Z-0910-2015Class IIMcKesson Cardiology ECG Management It is a software application designed to import, display, storDecember 19, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K151850McKesson CardiologyAugust 11, 2015
K133534MCKESSON CARDIOLOGY ECG MOBILEApril 18, 2014
K131497MCKESSON CARDIOLOGY HEMODecember 5, 2013
K113515HORIZON CARDIOLOGY ECG MANAGEMENTMarch 16, 2012
K112720MCKESSON HORIZON CARDIOLOGYJanuary 30, 2012