Medical Device Manufacturer · US , Vernon Hills , IL

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

69 submissions · 68 cleared · Since 1991

Recent clearances: Upper Arm Blood pressure monitor (BP7155D), Omron Model BP7900 Blood Pressure Monitor + EKG, Focus TENS Therapy, Model PM710-M/-L

69
Total
68
Cleared
1
Denied

Omron Healthcare, Inc. has 68 FDA 510(k) cleared medical devices. Based in Vernon Hills, US.

Latest FDA clearance: Sep 2026. 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, Underwriters Laboratories, Inc. and Promedic, Inc..

FDA 510(k) Regulatory Record - Omron Healthcare, Inc.

69 devices
1-12 of 69

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