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Terumo Corp.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K100282 TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERFOZ2010-02-26 View
510(k) K092372 HEARTRAIL III GUIDING CATHETERDQO2009-09-11 View
510(k) K091417 SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527AOCY2009-05-22 View
510(k) K090973 TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)FOZ2009-05-01 View
510(k) K073474 CAPIOX CIRCUIT CONNECTORSDTL2008-03-05 View
510(k) K071572 CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTERDTZ2007-07-23 View
510(k) K071494 CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTERDTZ2007-07-16 View
510(k) K071075 TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55ADXN2007-05-25 View
510(k) K040783 FOUNDATIONLYC2004-10-13 View
510(k) K040210 CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIRDTZ2004-03-03 View
510(k) K033681 GLIDESHEATHDYB2003-12-11 View
510(k) K031266 SURSHIELD SAFETY WINGED INFUSION SETFPA2003-05-30 View
510(k) K030449 MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIRDTN2003-03-05 View
510(k) K022115 CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIRDTZ2002-09-27 View
510(k) K003371 PUMP TUBING WITH X-COATINGDWF2000-12-21 View
510(k) K993189 CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBINGDWE2000-03-01 View
510(k) K983490 TERUMO VENOJECT,LUER ADAPTERJKA1998-11-30 View
510(k) K980796 TERUMO ALLERGY SYRINGEFMF1998-04-02 View
510(k) K943861 CAPIOX SP PUMP HEADKFM1995-08-15 View
510(k) K910969 TORQUE DEVICE FOR A GUIDE WIREDQX1991-05-16 View
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