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

901 results for "Abbott Laboratories"
49–72 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 28, 2012
ARCHITECT HAVAB-G
K113704 · LOL
Abbott Laboratories
Microbiology · 195d
Cleared May 17, 2012
ARCHITECT B12
K121314 · CDD
Abbott Laboratories
Chemistry · 15d
Cleared Apr 20, 2012
SAFETY SCREW CONNECTOR
K113719 · KNT
Abbott Laboratories
Gastroenterology & Urology · 123d
Cleared Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874 · LFR
Abbott Laboratories
Chemistry · 230d
Cleared Dec 22, 2011
CELL-DYN EMERALD 22 SYSTEM
K110381 · GKZ
Abbott Laboratories
Hematology · 315d
Cleared Oct 14, 2011
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
K103627 · KLT
Abbott Laboratories
Toxicology · 305d
Cleared Oct 06, 2011
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · CDD
Abbott Laboratories
Chemistry · 219d
Cleared Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023 · JIT
Abbott Laboratories
Chemistry · 58d
Cleared May 06, 2011
URIC ACID MODEL 3P39
K102568 · KNK
Abbott Laboratories
Chemistry · 241d
Cleared CT Apr 29, 2011
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY...
K110909 · NTE
Abbott Laboratories
Cardiovascular · 29d
Cleared Apr 01, 2011
ARCHITECT IGENTAMICIN REAGENTS
K102699 · LCD
Abbott Laboratories
Toxicology · 193d
Cleared Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
K103403 · JIX
Abbott Laboratories
Chemistry · 77d
Cleared Mar 05, 2010
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE...
K092740 · CGN
Abbott Laboratories
Chemistry · 178d
Cleared Feb 19, 2010
ACCELERATOR APS
K093318 · CEM
Abbott Laboratories
Chemistry · 119d
Cleared Aug 06, 2009
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS,...
K090358 · LEG
Abbott Laboratories, Inc.
Chemistry · 175d
Cleared Apr 07, 2009
CREATININE
K083809 · CGX
Abbott Laboratories
Chemistry · 106d
Cleared Feb 04, 2009
CELL-DYN EMERALD SYSTEM
K081495 · GKZ
Abbott Laboratories
Hematology · 251d
Cleared Sep 26, 2008
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS,...
K081231 · DLZ
Abbott Laboratories
Toxicology · 148d
Cleared Sep 11, 2008
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH...
K080696 · DIP
Abbott Laboratories
Toxicology · 183d
Cleared Aug 19, 2008
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · NTE
Abbott Laboratories
Cardiovascular · 77d
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · CIT
Abbott Laboratories
Chemistry · 289d
Cleared Oct 23, 2007
FOX SV PTA CATHETER
K072824 · LIT
Abbott Laboratories
Cardiovascular · 21d
Cleared Apr 16, 2007
ABBOTT ARCHITECT HAVAB-M
K063329 · LOL
Abbott Laboratories
Microbiology · 164d
Cleared Nov 22, 2006
CALCIUM
K062855 · CJY
Abbott Laboratories
Chemistry · 58d