Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

70 results for "Icu Medical, Inc."
25–48 of 70
Search insights Median review: 111d Cleared: 100% Top manufacturer: Icu Medical, Inc. Lead specialty: General Hospital
Cleared Feb 25, 2009
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · FMG
Icu Medical, Inc.
General Hospital · 152d
Cleared Aug 28, 2008
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
K081361 · FPA
Icu Medical, Inc.
General Hospital · 105d
Cleared May 13, 2008
GRADUATED ADAPTER WITH CLAVE
K080007 · EZD
Icu Medical, Inc.
Gastroenterology & Urology · 132d
Cleared May 02, 2008
UNIVERSAL VIAL ACCESS SPIKE
K080989 · FMF
Icu Medical, Inc.
General Hospital · 25d
Cleared Feb 13, 2008
CLAVE STOPCOCK
K080077 · FMG
Icu Medical, Inc.
General Hospital · 33d
Cleared Oct 05, 2007
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · FMF
Icu Medical, Inc.
General Hospital · 191d
Cleared Sep 19, 2007
PULL TAB SQUEEZE FLUSH
K070979 · KRA
Icu Medical, Inc.
Cardiovascular · 166d
Cleared Jun 05, 2007
GENIE, MODEL CH-200
K070633 · FMF
Icu Medical, Inc.
General Hospital · 90d
Cleared Apr 16, 2007
DYE MANAGEMENT SYSTEM
K063784 · DQO
Icu Medical, Inc.
Cardiovascular · 116d
Cleared Mar 20, 2007
SPIROS
K070532 · FPA
Icu Medical, Inc.
General Hospital · 22d
Cleared Feb 10, 2006
WILLCARE, MODEL GW-1020
K052594 · FRN
Icu Medical, Inc.
General Hospital · 142d
Cleared Jan 10, 2006
TEGO, MODEL D1000
K053106 · FPA
Icu Medical, Inc.
General Hospital · 67d
Cleared Dec 22, 2005
HOSPIRA CATH LAB CONVENIENCE KITS
K052865 · DQO
Icu Medical, Inc.
Cardiovascular · 72d
Cleared Aug 03, 2005
CML 1000
K051437 · FPA
Icu Medical, Inc.
General Hospital · 63d
Cleared Sep 01, 2004
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
K042182 · FPA
Icu Medical, Inc.
General Hospital · 21d
Cleared Aug 11, 2004
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
K040710 · FPA
Icu Medical, Inc.
General Hospital · 146d
Cleared Jul 28, 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410 · FPA
Icu Medical, Inc.
General Hospital · 62d
Cleared Apr 12, 2004
TALON INFUSION SET, MODEL IP XXXX
K033290 · FPA
Icu Medical, Inc.
General Hospital · 181d
Cleared Dec 04, 2003
CLC2000 CATHETER PATENCY DEVICE
K021692 · FPA
Icu Medical, Inc.
General Hospital · 561d
Cleared Jan 11, 2001
TAXOL ADMINISTRATION SET
K003513 · FPA
Icu Medical, Inc.
General Hospital · 58d
Cleared May 10, 2000
POSI-LINK
K000472 · FPA
Icu Medical, Inc.
General Hospital · 86d
Cleared Dec 24, 1998
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
K983559 · FJK
Icu Medical, Inc.
Gastroenterology & Urology · 72d
Cleared Jan 09, 1998
SMARTVALVE
K974589 · FPA
Icu Medical, Inc.
General Hospital · 31d
Cleared Nov 17, 1997
POSITIVE PRESSURE CONNECTOR
K973167 · FPA
Icu Medical, Inc.
General Hospital · 84d