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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
241–264 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 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
Cleared Nov 07, 2011
LAMINAR FLOW PHACO TIPS
K111882 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 129d
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 Oct 03, 2011
ARMADA 35/35LL PTA CATHETER
K111899 · LIT
Abbott Vascular
Cardiovascular · 90d
Cleared Sep 27, 2011
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
K111697 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 102d
Cleared Aug 31, 2011
STEERABLE GUIDE CATHETER
K112239 · DRA
Abbott Vascular
Cardiovascular · 27d