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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 21 Results
ProductCode: FPA Applicant: ICU MEDICAL, INC. Decision Date To: 02/07/2023
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chemoclave cytotoxic medication preparation and delivery system ICU Medical, Inc. K173477 08/31/2018
clave neutron ICU MEDICAL, INC. K100434 07/09/2010
high pressure sets-400 psi ICU MEDICAL, INC. K100576 12/17/2010
cml 1000 ICU MEDICAL, INC. K051437 08/03/2005
tego, model d1000 ICU MEDICAL, INC. K053106 01/10/2006
tego needle free access access device ICU MEDICAL, INC. K040710 08/11/2004
y clave connector with integrated check valve, model xi-3432 ICU MEDICAL, INC. K042182 09/01/2004
talon infusion set, model ip xxxx ICU MEDICAL, INC. K033290 04/12/2004
clc2000 catheter patency device ICU MEDICAL, INC. K021692 12/04/2003
posi-link ICU MEDICAL, INC. K000472 05/10/2000