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

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1,305 results for "abbott"
289–312 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
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