Omron Healthcare, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Omron Healthcare, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Omron Model BP7900 Blood Pressure Monitor + EKG, Focus TENS Therapy, Model PM710-M/-L, HEM-6410T-ZL Wrist Blood Pressure Monitor
68
Total
67
Cleared
1
Denied
Omron Healthcare, Inc. has 67 FDA 510(k) cleared medical devices. Based in Vernon Hills, US.
Last cleared in 2021. Active since 1991. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Omron Healthcare, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Experien Group, Omron Healthcare, Inc. C/O Promedic, LLC and Experien Group, LLC.
FDA 510(k) Regulatory Record - Omron Healthcare, Inc.
68 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
Sep 07, 2019
Focus TENS Therapy, Model PM710-M/-L
Neurology
292d
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
Jan 10, 2019
Maxpower Relief
Neurology
157d
Cleared
Nov 09, 2018
Heat Pain Pro
Neurology
106d
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
Oct 19, 2017
Avail
Neurology
101d
Cleared
Apr 20, 2017
HEM-9210T
Cardiovascular
154d
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