Medical Device Manufacturer · JP , Nakakoma-Gun, Yamanashi

Kofu Factory of Terumo Corp. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005

Recent clearances: Terumo Pen Injector Needle 34, SURFLASH SAFETY I.V. CATHETER, SURFFLASH(R) PLUS SAFETY I.V. CATHETER

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kofu Factory of Terumo Corp. General Hospital ✕

4 devices

1-4 of 4

Cleared Aug 05, 2014

Terumo Pen Injector Needle 34

General Hospital · 158d

Cleared May 30, 2014

SURFLASH SAFETY I.V. CATHETER

General Hospital · 28d

Cleared Nov 02, 2012

SURFFLASH(R) PLUS SAFETY I.V. CATHETER

General Hospital · 14d

Cleared Nov 23, 2005

TERUMO MICRO TAPERED PEN NEEDLE

General Hospital · 65d

Data Source

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

Last updated: Sep 18, 2026