Terumo Corp. is one of 11748 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Terumo Corp. - FDA 510(k) Cleared Devices
Recent clearances: TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER, HEARTRAIL III GUIDING CATHETER, SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
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.
Regulatory submissions have been managed by Regulatory Technology Services, LLC and Kema Quality B.V..
FDA 510(k) Regulatory Record - Terumo Corp.
21 devices
Cleared
Feb 26, 2010
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
General Hospital
25d
Cleared
Sep 11, 2009
HEARTRAIL III GUIDING CATHETER
Cardiovascular
37d
Cleared
May 22, 2009
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A,...
Gastroenterology & Urology
9d
Cleared
May 01, 2009
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
General Hospital
25d
Cleared
Mar 05, 2008
CAPIOX CIRCUIT CONNECTORS
Cardiovascular
85d
Cleared
Jul 23, 2007
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
Cardiovascular
45d
Cleared
Jul 16, 2007
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
Cardiovascular
47d
Cleared
May 25, 2007
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
Cardiovascular
39d
Cleared
Oct 13, 2004
FOUNDATION
Dental
201d
Cleared
Mar 03, 2004
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
Cardiovascular
33d
Cleared
Dec 11, 2003
GLIDESHEATH
Cardiovascular
17d
Cleared
May 30, 2003
SURSHIELD SAFETY WINGED INFUSION SET
General Hospital
39d
Cleared
Mar 05, 2003
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
Cardiovascular
22d
Cleared
Sep 27, 2002
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
Cardiovascular
88d
Cleared
Dec 21, 2000
PUMP TUBING WITH X-COATING
Cardiovascular
52d
Cleared
Mar 01, 2000
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS...
Cardiovascular
160d
Cleared
Nov 30, 1998
TERUMO VENOJECT,LUER ADAPTER
Chemistry
56d
Cleared
Apr 02, 1998
TERUMO ALLERGY SYRINGE
General Hospital
31d
Cleared
Aug 15, 1995
CAPIOX SP PUMP HEAD
Cardiovascular
372d
Cleared
May 16, 1991
TORQUE DEVICE FOR A GUIDE WIRE
Cardiovascular
71d
Cleared
Mar 21, 1991
450CM GUIDE WIRE FOR G.I. USE
Gastroenterology & Urology
29d