Terumo Corporation - FDA 510(k) Cleared Devices
Recent clearances: Ryurei, Pen Injector Needle 32.5, DualView Catheter
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Terumo Corporation Cardiovascular ✕
9 devices
Cleared
Mar 27, 2026
Ryurei
Cardiovascular
247d
Cleared
Jul 17, 2025
DualView Catheter
Cardiovascular
127d
Cleared
Nov 26, 2024
R2P Radifocus Glidewire Advantage
Cardiovascular
246d
Cleared
Aug 21, 2024
Glidewire GT-R
Cardiovascular
146d
Cleared
Mar 29, 2018
NaviCross 0.018
Cardiovascular
105d
Cleared
Sep 15, 2017
Glidewire GT
Cardiovascular
217d
Cleared
Mar 13, 2013
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
Cardiovascular
36d
Cleared
Mar 13, 2013
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
Cardiovascular
15d
Cleared
Jul 16, 2012
HEARTRAIL III GUIDING CATHETER
Cardiovascular
245d