Terumo Corp. - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Terumo Corp. Cardiovascular ✕
13 devices
Cleared
Sep 11, 2009
HEARTRAIL III GUIDING CATHETER
Cardiovascular
37d
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
Mar 03, 2004
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
Cardiovascular
33d
Cleared
Dec 11, 2003
GLIDESHEATH
Cardiovascular
17d
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
Aug 15, 1995
CAPIOX SP PUMP HEAD
Cardiovascular
372d
Cleared
May 16, 1991
TORQUE DEVICE FOR A GUIDE WIRE
Cardiovascular
71d