Medical Device Manufacturer · US , Rockville , MD

Otsuka America Pharmaceutical, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2023

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Otsuka America Pharmaceutical, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jun 30, 2025

Otsuka Digital Feedback Device

Cardiovascular · 82d

Cleared Aug 11, 2023

Otsuka Digital Feedback Device-RW

Cardiovascular · 268d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026