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

1,305 results for "abbott"
337–360 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 06, 2007
STARCLOSE HEX-HUB DILATOR
K062554 · DRE
Abbott Vascular, Inc.
Cardiovascular · 160d
Cleared Dec 14, 2006
COPILOT HEALTH MANAGEMENT SYSTEM
K062770 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Nov 22, 2006
CALCIUM
K062855 · CJY
Abbott Laboratories
Chemistry · 58d
Cleared Oct 17, 2006
FOX SV PTA CATHETER
K062843 · LIT
Abbott Laboratories
Cardiovascular · 25d
Cleared Sep 26, 2006
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
K062505 · MNI
Abbott Spine, Inc.
Orthopedic · 29d
Cleared Jul 10, 2006
CELL-DYN RUBY SYSTEM
K061667 · GKZ
Abbott Laboratories
Hematology · 26d
Cleared Jul 07, 2006
STARCLOSE INTRODUCER SET MODEL- 1002
K060902 · DYB
Abbott Vascular, Inc.
Cardiovascular · 95d
Cleared Jun 23, 2006
CREATININE
K061193 · CGX
Abbott Laboratories, Inc.
Chemistry · 56d
Cleared Jun 14, 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · MMI
Abbott Laboratories
Chemistry · 76d
Cleared Jun 02, 2006
AXSYM DIGOXIN III
K061249 · KXT
Abbott Laboratories
Toxicology · 29d
Cleared May 05, 2006
GLUCOSE
K060383 · CFR
Abbott Laboratories
Chemistry · 80d
Cleared May 04, 2006
CARBON DIOXIDE
K060295 · KHS
Abbott Laboratories
Chemistry · 87d
Cleared May 03, 2006
TOTAL BILIRUBIN
K060574 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared Apr 21, 2006
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K060768 · JIN
Abbott Diabetes Care, Inc.
Chemistry · 30d
Cleared Mar 31, 2006
NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
K060634 · MNI
Abbott Spine, Inc.
Orthopedic · 22d
Cleared Mar 09, 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 245d
Cleared Mar 06, 2006
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
K060009 · JDQ
Abbott Spine, Inc.
Orthopedic · 62d
Cleared Jan 13, 2006
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+...
K053110 · JGS
I-Stat Corporation
Chemistry · 70d
Cleared Jan 06, 2006
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113,...
K052566 · MNI
Abbott Spine, Inc.
Orthopedic · 109d
Cleared Dec 23, 2005
INSULIN PUMP
K051041 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 242d
Cleared Dec 16, 2005
ARCHITECT B12 CALIBRATORS
K053330 · JIT
Abbott Laboratories
Chemistry · 15d
Cleared Nov 07, 2005
ABBOTT SPINE, INC. SPINNAKER SYSTEM
K052638 · KNW
Abbott Spine, Inc.
Gastroenterology & Urology · 42d
Cleared Sep 14, 2005
THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
K052454 · NTE
Abbott Vascular Devices
Cardiovascular · 8d
Cleared Sep 14, 2005
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
K052247 · KWP
Abbott Spine, Inc.
Orthopedic · 27d