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"
241–264 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · CIG
Abbott Laboratories
Chemistry · 210d
Cleared CT Jan 30, 2013
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK...
K123279 · LOX
Abbott Vascular
Cardiovascular · 100d
Cleared CT Jan 29, 2013
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
K123067 · DQX
Abbott Vascular, Inc.
Cardiovascular · 120d
Cleared Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
K123372 · JIX
Abbott Laboratories
Chemistry · 74d
Cleared Dec 21, 2012
ABBOTT PLEX-ID FLU ASSAY
K121003 · OCC
Abbott Laboratories
Microbiology · 263d
Cleared Dec 13, 2012
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS...
K120936 · DKB
Microgenics Corporation
Toxicology · 260d
Cleared Nov 27, 2012
ABBOTT ARCHITECT FREE T4
K123379 · CEC
Abbott Laboratories
Chemistry · 26d
Cleared Nov 20, 2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
K122573 · DQX
Abbott Vascular, Inc.
Cardiovascular · 89d
Cleared Oct 15, 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
K121721 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 125d
Cleared Sep 11, 2012
TESTOSTERONE TEST SYSTEM
K120009 · CDZ
Abbott Laboratories
Chemistry · 252d
Cleared Aug 15, 2012
ARMADA 14XXT PTA CATHETER
K121352 · DQY
Abbott Vascular
Cardiovascular · 103d
Cleared Jun 28, 2012
ARCHITECT HAVAB-G
K113704 · LOL
Abbott Laboratories
Microbiology · 195d
Cleared Jun 22, 2012
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
K121222 · LOX
Abbott Vascular
Cardiovascular · 60d
Cleared May 17, 2012
ARCHITECT B12
K121314 · CDD
Abbott Laboratories
Chemistry · 15d
Cleared May 04, 2012
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K121015 · NTE
Abbott Vascular
Cardiovascular · 30d
Cleared Apr 20, 2012
SAFETY SCREW CONNECTOR
K113719 · KNT
Abbott Laboratories
Gastroenterology & Urology · 123d
Cleared Mar 29, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 31d
Cleared CT Mar 08, 2012
IFS LASER SYSTEM
K113151 · GEX
Abbott Medical Optics, Inc.
General & Plastic Surgery · 135d
Cleared Mar 06, 2012
NC TREK OTW CORONARY DILATATION CATHETER
K113464 · LOX
Abbott Vascular
Cardiovascular · 105d
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 Dec 21, 2011
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
K111446 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 211d
Cleared Dec 20, 2011
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
K112430 · KHP
Abbott Pont of Care, Inc.
Chemistry · 118d
Cleared Nov 08, 2011
HI-TORQUE POWERTURN
K112957 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 35d