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"
1057–1080 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 26, 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · GKL
Abbott Diagnostics
Hematology · 89d
Cleared Mar 19, 1985
ABBOTT INPERSOL CYCLER 1000
K845042 · FKX
Abbott Laboratories
Gastroenterology & Urology · 81d
Cleared Mar 01, 1985
ABBOTT RF EIA DIAGNOSTIC KIT
K850373 · DHR
Abbott Laboratories
Chemistry · 29d
Cleared Feb 21, 1985
CAPD STAGED CONNECTOR
K845041 · FKO
Abbott Laboratories
Gastroenterology & Urology · 55d
Cleared Feb 15, 1985
NUTRIMIX EMPTY CONTAINER
K844077 · KPE
Abbott Laboratories
General Hospital · 119d
Cleared Feb 12, 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · JHJ
Abbott Laboratories
Chemistry · 56d
Cleared Feb 06, 1985
TDX ETHOSUXIMIDE
K850174 · DLF
Abbott Laboratories
Toxicology · 20d
Cleared Feb 04, 1985
VISION TRIGLYCERIDES
K850031 · CDT
Abbott Laboratories
Chemistry · 28d
Cleared Jan 29, 1985
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
K850110 · CJE
Abbott Laboratories
Chemistry · 15d
Cleared Jan 25, 1985
ABBOTT LIFECARE 500 INFUSER
K844768 · FRN
Abbott Laboratories
General Hospital · 49d
Cleared Jan 25, 1985
ABBOTT LIFECARE 900 VOLUMETRIC PUMP
K844091 · FRN
Abbott Laboratories
General Hospital · 95d
Cleared Jan 18, 1985
TDX TOTAL ESTRIOL
K844511 · CGI
Abbott Laboratories
Chemistry · 59d
Cleared Jan 08, 1985
FOCUS UREA NITROGEN
K844755 · CDQ
Abbott Laboratories
Chemistry · 33d
Cleared Nov 27, 1984
ADD-1
K844114 · JJE
Abbott Laboratories
Chemistry · 35d
Cleared Nov 27, 1984
TDX SALICYLATE
K844070 · DKJ
Abbott Laboratories
Chemistry · 40d
Cleared Nov 02, 1984
ABBOTT HTSH EIA DIAGNOSTIC KIT
K843540 · JLW
Abbott Laboratories
Chemistry · 56d
Cleared Oct 30, 1984
FOCUS URIC ACID
K844011 · KNK
Abbott Laboratories
Chemistry · 18d
Cleared Oct 30, 1984
TDX REA CREATININE
K843916 · CGX
Abbott Laboratories
Chemistry · 25d
Cleared Sep 28, 1984
PDA GLUCOSE
K843541 · CFR
Abbott Laboratories
Chemistry · 21d
Cleared Sep 28, 1984
PDA CHOLESTEROL
K843510 · CHH
Abbott Laboratories
Chemistry · 22d
Cleared Sep 14, 1984
DYNA-LYTE 2000
K842786 · CEM
Abbott Diagnostics
Chemistry · 115d
Cleared Sep 06, 1984
DILU-MATIC 140
K842446 · GKH
Abbott Diagnostics
Hematology · 77d
Cleared Aug 29, 1984
TDX DISOPYRAMIDE
K842713 · LBZ
Abbott Laboratories
Chemistry · 48d
Cleared Aug 16, 1984
TDX DIGITOXIN
K842280 · LFM
Abbott Laboratories
Toxicology · 69d