Omron Healthcare, Inc. - FDA 510(k) Cleared Devices
68
Total
67
Cleared
1
Denied
FDA 510(k) cleared devices by Omron Healthcare, Inc. Cardiovascular ✕
41 devices
Not Cleared
Oct 08, 2024
Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection...
Cardiovascular
330d
Cleared
Apr 01, 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
Cardiovascular
237d
Cleared
Apr 17, 2019
HEM-6410T-ZL Wrist Blood Pressure Monitor
Cardiovascular
30d
Cleared
Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
Cardiovascular
176d
Cleared
Nov 09, 2018
HEM-6410T-ZM Wrist Blood Pressure Monitor
Cardiovascular
60d
Cleared
Nov 08, 2018
Wrist Blood Pressure Monitor Model BP4350
Cardiovascular
90d
Cleared
Nov 02, 2018
Wrist Blood Pressure Monitor Model BP6100
Cardiovascular
88d
Cleared
Apr 20, 2017
HEM-9210T
Cardiovascular
154d
Cleared
Feb 21, 2017
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
Cardiovascular
113d
Cleared
Nov 22, 2016
Evolv Model BP7000 Upper Arm Blood Pressure Monitor
Cardiovascular
117d
Cleared
Dec 01, 2014
BP652N (HEM-6300-Z)
Cardiovascular
55d
Cleared
Mar 04, 2014
HEM-7320
Cardiovascular
120d
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