FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

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