Medical Device Manufacturer · US , Durham , NC

Tokyo Boeki Medisys, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2011

Recent clearances: BIOLIS 12I, PRESTIGE 24I

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tokyo Boeki Medisys, Inc. Chemistry ✕

2 devices

1-2 of 2

Cleared Mar 23, 2012

Chemistry · 394d

Cleared Dec 01, 2011

Chemistry · 365d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 15, 2026