FDA 510(k) Applications Submitted by TERUMO Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K130280 02/05/2013 CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR TERUMO Corporation
K130493 02/26/2013 CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR TERUMO Corporation
K113335 11/14/2011 HEARTRAIL III GUIDING CATHETER TERUMO Corporation
K170417 02/10/2017 Glidewire GT Terumo Corporation
K190427 02/22/2019 Immucise Terumo Corporation
K122544 08/21/2012 TERUMO SURFLASH SAFETY I.V. CATHETER TERUMO Corporation
K181369 05/23/2018 Immucise Intradermal Injection System Terumo Corporation
K173799 12/14/2017 NaviCross 0.018 Terumo Corporation


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