Medical Device Manufacturer · US , Vernon Hills , IL

Omron Healthcare, Inc. - FDA 510(k) Cleared Devices

68 submissions · 67 cleared · Since 1991

Total

Cleared

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.

FDA 510(k) cleared devices by Omron Healthcare, Inc.

68 devices

1-12 of 68

Not Cleared Oct 08, 2024

Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection...

DEN230076 · QXY

Cardiovascular · 330d

Cleared Apr 01, 2021

Omron Model BP7900 Blood Pressure Monitor + EKG

K202228 · DXN

Cardiovascular · 237d

Cleared Sep 07, 2019

Focus TENS Therapy, Model PM710-M/-L

K183215 · NUH

Neurology · 292d

Cleared Apr 17, 2019

HEM-6410T-ZL Wrist Blood Pressure Monitor

K190693 · DXN

Cardiovascular · 30d

Cleared Mar 14, 2019

Omron Model BP7900 Blood Pressure Monitor + EKG

K182579 · DXN

Cardiovascular · 176d

HEM-6410T-ZM Wrist Blood Pressure Monitor

K182481 · DXN

Cardiovascular · 60d

Cleared Nov 08, 2018

Wrist Blood Pressure Monitor Model BP4350

K182166 · DXN

Cardiovascular · 90d

Cleared Nov 02, 2018

Wrist Blood Pressure Monitor Model BP6100

Cardiovascular · 154d

Looking for a specific device from Omron Healthcare, Inc.? Search by device name or K-number.

Search all Omron Healthcare, Inc. devices

Omron Healthcare, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Omron Healthcare, Inc.

Filters