Medical Device Manufacturer · US , Somerset , NJ

Terumo Corp. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1991
21
Total
21
Cleared
0
Denied

Terumo Corp. has 21 FDA 510(k) cleared medical devices. Based in Somerset, US.

Historical record: 21 cleared submissions from 1991 to 2010. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Terumo Corp. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Terumo Corp.

21 devices
1-21 of 21
Cleared Feb 26, 2010
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
K100282 · FOZ
General Hospital · 25d
Cleared Sep 11, 2009
HEARTRAIL III GUIDING CATHETER
K092372 · DQO
Cardiovascular · 37d
Cleared May 22, 2009
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A,...
K091417 · OCY
Gastroenterology & Urology · 9d
Cleared May 01, 2009
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
K090973 · FOZ
General Hospital · 25d
Cleared Mar 05, 2008
CAPIOX CIRCUIT CONNECTORS
K073474 · DTL
Cardiovascular · 85d
Cleared Jul 23, 2007
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
K071572 · DTZ
Cardiovascular · 45d
Cleared Jul 16, 2007
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
K071494 · DTZ
Cardiovascular · 47d
Cleared May 25, 2007
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
K071075 · DXN
Cardiovascular · 39d
Cleared Oct 13, 2004
FOUNDATION
K040783 · LYC
Dental · 201d
Cleared Mar 03, 2004
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
K040210 · DTZ
Cardiovascular · 33d
Cleared Dec 11, 2003
GLIDESHEATH
K033681 · DYB
Cardiovascular · 17d
Cleared May 30, 2003
SURSHIELD SAFETY WINGED INFUSION SET
K031266 · FPA
General Hospital · 39d
Cleared Mar 05, 2003
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K030449 · DTN
Cardiovascular · 22d
Cleared Sep 27, 2002
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
K022115 · DTZ
Cardiovascular · 88d
Cleared Dec 21, 2000
PUMP TUBING WITH X-COATING
K003371 · DWF
Cardiovascular · 52d
Cleared Mar 01, 2000
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS...
K993189 · DWE
Cardiovascular · 160d
Cleared Nov 30, 1998
TERUMO VENOJECT,LUER ADAPTER
K983490 · JKA
Chemistry · 56d
Cleared Apr 02, 1998
TERUMO ALLERGY SYRINGE
K980796 · FMF
General Hospital · 31d
Cleared Aug 15, 1995
CAPIOX SP PUMP HEAD
K943861 · KFM
Cardiovascular · 372d
Cleared May 16, 1991
TORQUE DEVICE FOR A GUIDE WIRE
K910969 · DQX
Cardiovascular · 71d
Cleared Mar 21, 1991
450CM GUIDE WIRE FOR G.I. USE
K910722 · OCY
Gastroenterology & Urology · 29d
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