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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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