Terumo Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERFebruary 26, 2010
K092372HEARTRAIL III GUIDING CATHETERSeptember 11, 2009
K091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-May 22, 2009
K090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)May 1, 2009
K073474CAPIOX CIRCUIT CONNECTORSMarch 5, 2008
K071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTERJuly 23, 2007
K071494CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTERJuly 16, 2007
K071075TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55AMay 25, 2007
K040783FOUNDATIONOctober 13, 2004
K040210CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIRMarch 3, 2004
K033681GLIDESHEATHDecember 11, 2003
K031266SURSHIELD SAFETY WINGED INFUSION SETMay 30, 2003
K030449MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIRMarch 5, 2003
K022115CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIRSeptember 27, 2002
K003371PUMP TUBING WITH X-COATINGDecember 21, 2000
K993189CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH March 1, 2000
K983490TERUMO VENOJECT,LUER ADAPTERNovember 30, 1998
K980796TERUMO ALLERGY SYRINGEApril 2, 1998
K943861CAPIOX SP PUMP HEADAugust 15, 1995
K910969TORQUE DEVICE FOR A GUIDE WIREMay 16, 1991