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"
289–312 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 19, 2010
ACCELERATOR APS
K093318 · CEM
Abbott Laboratories
Chemistry · 119d
Cleared Sep 25, 2009
HI-TORQUE PROGRESS GUIDE WIRE FAMILY
K091825 · DQX
Abbott Vascular, Inc.
Cardiovascular · 98d
Cleared Aug 27, 2009
FOX SV PTA CATHETER
K092286 · LIT
Abbott Vascular
Cardiovascular · 29d
Cleared Aug 06, 2009
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS,...
K090358 · LEG
Abbott Laboratories, Inc.
Chemistry · 175d
Cleared Jun 02, 2009
NEXLINK OCT SYSTEM, MODEL 7000 SERIES
K090060 · KWP
Abbott Spine, Inc.
Orthopedic · 144d
Cleared May 22, 2009
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
K090665 · NTE
Abbott Vascular-Vascular Solutions
Cardiovascular · 70d
Cleared Apr 16, 2009
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20...
K083223 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 164d
Cleared Apr 07, 2009
CREATININE
K083809 · CGX
Abbott Laboratories
Chemistry · 106d
Cleared Mar 20, 2009
FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS...
K090509 · DQY
Abbott Vascular-Vascular Solutions
Cardiovascular · 22d
Cleared Mar 11, 2009
HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
K083738 · DQX
Abbott Vascular
Cardiovascular · 85d
Cleared Feb 25, 2009
TAD AND TAD II TAPERED GUIDE WIRES
K083732 · DQX
Abbott Vascular
Cardiovascular · 71d
Cleared Feb 23, 2009
.035 LOC GUIDE WIRE EXTENSION
K083713 · DQX
Abbott Vascular
Cardiovascular · 70d
Cleared Feb 20, 2009
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 109d
Cleared Feb 06, 2009
HI-TORQUE VERSACORE GUIDE WIRE
K083706 · DQX
Abbott Vascular
Cardiovascular · 53d
Cleared Feb 04, 2009
CELL-DYN EMERALD SYSTEM
K081495 · GKZ
Abbott Laboratories
Hematology · 251d
Cleared Nov 26, 2008
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01...
K081975 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 138d
Cleared Oct 06, 2008
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS...
K082032 · NKB
Abbott Spine, Inc.
Orthopedic · 81d
Cleared Sep 26, 2008
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS,...
K081231 · DLZ
Abbott Laboratories
Toxicology · 148d
Cleared Sep 11, 2008
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K081523 · NTE
Abbott Vascular-Vascular Solutions
Cardiovascular · 101d
Cleared Sep 11, 2008
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH...
K080696 · DIP
Abbott Laboratories
Toxicology · 183d
Cleared Sep 05, 2008
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS...
K080960 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 155d
Cleared Aug 29, 2008
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K081622 · JDQ
Abbott Spine, Inc.
Orthopedic · 80d
Cleared Aug 19, 2008
RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
K081549 · NTE
Abbott Laboratories
Cardiovascular · 77d
Cleared Aug 18, 2008
ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
K072708 · FGE
Abbott Vascular-Vascular Solutions
Gastroenterology & Urology · 328d