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"
265–288 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Aug 29, 2011
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721,...
K091960 · OWK
Abbott Molecular, Inc.
Pathology · 789d
Cleared Aug 09, 2011
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN)...
K100015 · OVQ
Abbott Molecular, Inc.
Pathology · 582d
Cleared Jun 10, 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023 · JIT
Abbott Laboratories
Chemistry · 58d
Cleared CT Jun 02, 2011
MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM...
K110617 · LOX
Abbott Vascular
Cardiovascular · 91d
Cleared Jun 01, 2011
UNIT, PHACOFRAGMENTATION
K103023 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 232d
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 11, 2011
NC TREK RX CORONARY DILATATION CATHETER
K110134 · LOX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 24d
Cleared Feb 10, 2011
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
K103101 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 113d
Cleared Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
K103195 · CGA
Abbott Point of Care, Inc.
Chemistry · 102d
Cleared Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
K103403 · JIX
Abbott Laboratories
Chemistry · 77d
Cleared Jan 10, 2011
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM)...
K103110 · LOX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 94d
Cleared Dec 30, 2010
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION...
K103153 · LOX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 77d
Cleared Dec 07, 2010
ARMADA 14 PTA CATHETER
K102705 · LIT
Abbott Vascular, Inc.
Cardiovascular · 78d
Cleared Sep 15, 2010
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
K093254 · LPN
Abbott Medical Optics, Inc.
Ophthalmic · 334d
Cleared Jul 08, 2010
HI-TORQUE WINN GUIDE WIRE FAMILY
K101648 · DQX
Abbott Vascular, Inc.
Cardiovascular · 27d
Cleared Jun 23, 2010
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING,...
K101116 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 63d