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Icu Medical, Inc.

66 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
LifeShield Infusion Safety Software Suite (K252130)Icu Medical, Inc.2026-04-02
OTTO™ Disinfecting Cap (K252006)Icu Medical, Inc.2026-03-27
ClaveQS™ Bag (K251980)Icu Medical, Inc.2026-03-20
Clave™ Neutral-Displacement Needlefree Connectors (K250616)Icu Medical, Inc.2025-06-05
LifeShield Infusion Safety Software Suite (K242117)Icu Medical, Inc.2025-04-02
Plum Solo™ Precision IV Pump (K242114)Icu Medical, Inc.2025-04-02
Plum Duo™ Precision IV Pump (K242115)Icu Medical, Inc.2025-04-02
Rio™ Drug Reconstitution Transfer Device (K243985)Icu Medical, Inc.2025-01-22
Plum Duo™ Infusion System (K223607)Icu Medical, Inc.2023-08-24
LifeShield™ Infusion Safety Software Suite (K223606)Icu Medical, Inc.2023-08-24
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System (K173477)Icu Medical, Inc.2018-08-31
Diana Medication Transfer Set (K170110)Icu Medical, Inc.2018-08-10
Cogent Hemodynamic Monitoring System (K152006)Icu Medical, Inc.2016-05-05
Hospira Extension Sets (K151969)Icu Medical, Inc.2016-01-19
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER (K140129)Icu Medical, Inc.2014-07-02
CHEMOLOCK, CHEMOLOCK PORT (K131549)Icu Medical, Inc.2013-07-26
HIGH PRESSURE SETS-400 PSI (K100576)Icu Medical, Inc.2010-12-17
CLAVE NEUTRON (K100434)Icu Medical, Inc.2010-07-09
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE (K090189)Icu Medical, Inc.2009-04-10
SPINNING SPIROS, MODEL CH-2000 (K082806)Icu Medical, Inc.2009-04-06
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES (K082836)Icu Medical, Inc.2009-02-25
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX (K081361)Icu Medical, Inc.2008-08-28
GRADUATED ADAPTER WITH CLAVE (K080007)Icu Medical, Inc.2008-05-13
UNIVERSAL VIAL ACCESS SPIKE (K080989)Icu Medical, Inc.2008-05-02
CLAVE STOPCOCK (K080077)Icu Medical, Inc.2008-02-13
ICU MEDICAL SINGLE-USE SYRINGE (K070856)Icu Medical, Inc.2007-10-05
PULL TAB SQUEEZE FLUSH (K070979)Icu Medical, Inc.2007-09-19
GENIE, MODEL CH-200 (K070633)Icu Medical, Inc.2007-06-05
DYE MANAGEMENT SYSTEM (K063784)Icu Medical, Inc.2007-04-16
SPIROS (K070532)Icu Medical, Inc.2007-03-20
WILLCARE, MODEL GW-1020 (K052594)Icu Medical, Inc.2006-02-10
TEGO, MODEL D1000 (K053106)Icu Medical, Inc.2006-01-10
HOSPIRA CATH LAB CONVENIENCE KITS (K052865)Icu Medical, Inc.2005-12-22
CML 1000 (K051437)Icu Medical, Inc.2005-08-03
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 (K042182)Icu Medical, Inc.2004-09-01
TEGO NEEDLE FREE ACCESS ACCESS DEVICE (K040710)Icu Medical, Inc.2004-08-11
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 (K041410)Icu Medical, Inc.2004-07-28
TALON INFUSION SET, MODEL IP XXXX (K033290)Icu Medical, Inc.2004-04-12
CLC2000 CATHETER PATENCY DEVICE (K021692)Icu Medical, Inc.2003-12-04
TAXOL ADMINISTRATION SET (K003513)Icu Medical, Inc.2001-01-11
POSI-LINK (K000472)Icu Medical, Inc.2000-05-10
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR (K983559)Icu Medical, Inc.1998-12-24
SMARTVALVE (K974589)Icu Medical, Inc.1998-01-09
POSITIVE PRESSURE CONNECTOR (K973167)Icu Medical, Inc.1997-11-17
CORE RESISTANT HUBER INFUSION SETS (K972712)Icu Medical, Inc.1997-10-01
CLAVE CONNECTOR (K970855)Icu Medical, Inc.1997-06-24
PRIMARY IV SET (K964435)Icu Medical, Inc.1997-04-02
ICU EXTENSION KIT (K954813)Icu Medical, Inc.1995-11-29
ICU STOPCOK WITH EXTENSION TUBING (K953573)Icu Medical, Inc.1995-10-07
CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET (K941190)Icu Medical, Inc.1995-01-31
SAFE CONNECTOR (K940296)Icu Medical, Inc.1994-02-22
CLAVE VIAL ACCESS SPIKE (K934591)Icu Medical, Inc.1994-02-16
ONE TIME VIAL ACCESS SPIKE (K934561)Icu Medical, Inc.1994-02-10
LOPEZ VALVE WITH NG SUMP TUBE (K921104)Icu Medical, Inc.1992-10-26
CLAVE CONNECTOR (K915571)Icu Medical, Inc.1992-09-21
GI BLEEDER/OD SET (K913476)Icu Medical, Inc.1992-02-12
LOPEZ VALVE TM II (K915171)Icu Medical, Inc.1992-02-07
PIGGY LOCK NEEDLE HOUSING (K910546)Icu Medical, Inc.1991-04-29
HR VACUTRAC (K881201)Icu Medical, Inc.1988-05-16
HR(TM) INTRAVASCULAR CATHETER (K881666)Icu Medical, Inc.1988-05-06
HR(TM) NEEDLE AND SYRINGE (K874372)Icu Medical, Inc.1987-11-06
HR (TM) COLLECTION SYSTEM (K872580)Icu Medical, Inc.1987-08-13
LOPEZ VALVE (K861586)Icu Medical, Inc.1986-08-18
ICU MEDICAL NEEDLE, LOPEZ NEEDLE (K860781)Icu Medical, Inc.1986-05-06
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD (K853275)Icu Medical, Inc.1985-08-16
LOPEZ LOCK (K840273)Icu Medical, Inc.1984-03-06

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Every clearance here is in the API, with alerts when new ones post.