Medical Device Manufacturer · JP , Shibuya-Ku, Tokyo

Terumo Corporation - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2012

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Terumo Corporation General Hospital ✕

4 devices

1-4 of 4

Cleared Nov 21, 2025

Pen Injector Needle 32.5

General Hospital · 259d

Cleared Jul 18, 2019

General Hospital · 146d

Cleared Nov 13, 2018

Immucise Intradermal Injection System

General Hospital · 174d

Cleared Sep 05, 2012

TERUMO SURFLASH SAFETY I.V. CATHETER

General Hospital · 15d

Data Source

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

Last updated: Apr 27, 2026