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"
265–288 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 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 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
Cleared Jun 15, 2010
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21,...
K092638 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 292d
Cleared May 28, 2010
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02...
K092705 · OOI
Abbott Molecular, Inc.
Microbiology · 267d
Cleared May 28, 2010
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT,...
K092704 · LSK
Abbott Molecular, Inc.
Microbiology · 267d
Cleared May 24, 2010
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
K101011 · DQX
Abbott Vascular, Inc.
Cardiovascular · 42d
Cleared May 14, 2010
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite...
K092602 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 262d
Cleared Mar 05, 2010
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE...
K092740 · CGN
Abbott Laboratories
Chemistry · 178d