ClearanceBrief
Company ยท US

Terumo Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2026. Name variants (Inc, Corp, punctuation) are merged.

34510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DTZOxygenator, Cardiopulmonary Bypass6
DQXWire, Guide, Catheter4
DQOCatheter, Intravascular, Diagnostic3
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days3
FMFSyringe, Piston2
FMINeedle, Hypodermic, Single Lumen2
OCYEndoscopic Guidewire, Gastroenterology-Urology2
DQYCatheter, Percutaneous1
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1
DTNReservoir, Blood, Cardiopulmonary Bypass1
DWETubing, Pump, Cardiopulmonary Bypass1
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1
DXNSystem, Measurement, Blood-Pressure, Non-Invasive1
DYBIntroducer, Catheter1
FPASet, Administration, Intravascular1
JKATubes, Vials, Systems, Serum Separators, Blood Collection1
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type1
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous1
LYCBone Grafting Material, Synthetic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 27, 2026K252295Ryurei
Terumo Corporation, JP
LOX
Nov 21, 2025K250700Pen Injector Needle 32.5
Terumo Corporation, JP
FMI
Jul 17, 2025K250751DualView Catheter
Terumo Corporation, JP
DQO
Nov 26, 2024K240818R2P Radifocus Glidewire Advantage
Terumo Corporation, JP
DQX
Aug 21, 2024K240859Glidewire GT-R
Terumo Corporation, JP
DQX
Jul 18, 2019K190427Immucise
Terumo Corporation, JP
FMF
Nov 13, 2018K181369Immucise Intradermal Injection System
Terumo Corporation, JP
FMI
Mar 29, 2018K173799NaviCross 0.018
Terumo Corporation, JP
DQY
Sep 15, 2017K170417Glidewire GT
Terumo Corporation, JP
DQX
Mar 13, 2013K130493CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
Terumo Corporation
DTZ
Mar 13, 2013K130280CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
Terumo Corporation
DTZ
Sep 5, 2012K122544TERUMO SURFLASH SAFETY I.V. CATHETER
Terumo Corporation, JP
FOZ
Jul 16, 2012K113335HEARTRAIL III GUIDING CATHETER
Terumo Corporation, JP
DQO
Feb 26, 2010K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
Terumo Corp.
FOZ
Sep 11, 2009K092372HEARTRAIL III GUIDING CATHETER
Terumo Corp.
DQO
May 22, 2009K091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
Terumo Corp.
OCY
May 1, 2009K090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
Terumo Corp.
FOZ
Mar 5, 2008K073474CAPIOX CIRCUIT CONNECTORS
Terumo Corp.
DTL
Jul 23, 2007K071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
Terumo Corp.
DTZ
Jul 16, 2007K071494CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
Terumo Corp.
DTZ
May 25, 2007K071075TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
Terumo Corp., JP
DXN
Oct 13, 2004K040783FOUNDATION
Terumo Corp.
LYC
Mar 3, 2004K040210CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
Terumo Corp.
DTZ
Dec 11, 2003K033681GLIDESHEATH
Terumo Corp.
DYB
May 30, 2003K031266SURSHIELD SAFETY WINGED INFUSION SET
Terumo Corp.
FPA
Mar 5, 2003K030449MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
Terumo Corp.
DTN
Sep 27, 2002K022115CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
Terumo Corp.
DTZ
Dec 21, 2000K003371PUMP TUBING WITH X-COATING
Terumo Corp.
DWF
Mar 1, 2000K993189CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
Terumo Corp.
DWE
Nov 30, 1998K983490TERUMO VENOJECT,LUER ADAPTER
Terumo Corp.
JKA
Apr 2, 1998K980796TERUMO ALLERGY SYRINGE
Terumo Corp.
FMF
Aug 15, 1995K943861CAPIOX SP PUMP HEAD
Terumo Corp.
KFM
May 16, 1991K910969TORQUE DEVICE FOR A GUIDE WIRE
Terumo Corp.
DQX
Mar 21, 1991K910722450CM GUIDE WIRE FOR G.I. USE
Terumo Corp.
OCY

Latest recalls

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