Medical Device Manufacturer · JP , Shibuya-Ku, Tokyo

Terumo Corporation

12 submissions · 12 cleared · Since 2012
12
Total
12
Cleared
0
Denied

Terumo Corporation — FDA 510(k) Submissions

Terumo Corporation has submitted 12 FDA 510(k) premarket notifications since 2012, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wire, Guide, Catheter, Oxygenator, Cardiopulmonary Bypass, Needle, Hypodermic, Single Lumen, Catheter, Intravascular, Diagnostic, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Pen Injector Needle 32.5
K250700 · FMI Needle, Hypodermic,... · General Hospital
Nov 2025 259d
DualView Catheter
K250751 · DQO Catheter, Intravascular,... · Cardiovascular
Jul 2025 127d
R2P Radifocus Glidewire Advantage
K240818 · DQX Wire, Guide, Catheter · Cardiovascular
Nov 2024 246d
Glidewire GT-R
K240859 · DQX Wire, Guide, Catheter · Cardiovascular
Aug 2024 146d
Immucise
K190427 · FMF Syringe, Piston · General Hospital
Jul 2019 146d
Immucise Intradermal Injection System
K181369 · FMI Needle, Hypodermic,... · General Hospital
Nov 2018 174d
NaviCross 0.018
K173799 · DQY Catheter, Percutaneous · Cardiovascular
Mar 2018 105d
Glidewire GT
K170417 · DQX Wire, Guide, Catheter · Cardiovascular
Sep 2017 217d
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
K130280 · DTZ Oxygenator,... · Cardiovascular
Mar 2013 36d
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
K130493 · DTZ Oxygenator,... · Cardiovascular
Mar 2013 15d
TERUMO SURFLASH SAFETY I.V. CATHETER
K122544 · FOZ Catheter, Intravascular,... · General Hospital
Sep 2012 15d
HEARTRAIL III GUIDING CATHETER
K113335 · DQO Catheter, Intravascular,... · Cardiovascular
Jul 2012 245d
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