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"
457–480 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 05, 2000
CONNECT DATA MANAGEMENT SYSTEM
K994433 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 127d
Cleared Mar 24, 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY...
K000821 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Jan 27, 2000
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS
K993031 · DLZ
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · KLS
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
K993028 · KLT
Syva Co.
Toxicology · 140d
Cleared Jan 14, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared Dec 22, 1999
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR...
K994039 · FRN
Abbott Laboratories
General Hospital · 23d
Cleared Nov 24, 1999
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
K992710 · JJY
Abbott Laboratories
Immunology · 105d
Cleared Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · LCP
Abbott Laboratories
Hematology · 187d
Cleared Oct 25, 1999
ABBOTT AXSYM HOMOCYSTEINE
K992858 · LPS
Abbott Laboratories
Chemistry · 61d
Cleared Oct 05, 1999
ALCYON 300I (WITH ISE MODULE) ANALYZER
K993083 · CEM
Abbott Laboratories
Chemistry · 20d
Cleared Sep 24, 1999
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · GKZ
Abbott Laboratories
Hematology · 64d
Cleared Aug 25, 1999
FLEXIFLO ENTERAL FEEDING TUBE
K992494 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Jul 09, 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700...
K991605 · GKZ
Abbott Laboratories
Hematology · 60d
Cleared Jun 23, 1999
CELL-DYN 1200 SYSTEM
K991142 · GKZ
Abbott Laboratories
Hematology · 79d
Cleared Jun 01, 1999
CRP
K991372 · DCN
Abbott Laboratories
Immunology · 42d
Cleared May 28, 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · CIG
Abbott Laboratories
Chemistry · 60d
Cleared May 19, 1999
ACP
K991010 · CKB
Abbott Diagnostics Mfg., Inc.
Chemistry · 54d
Cleared May 13, 1999
ACCLAIM INFUSION PUMP
K991501 · FRN
Abbott Laboratories
General Hospital · 14d
Cleared May 11, 1999
ABBOTT ARCHITECT CEA
K990774 · DHX
Abbott Laboratories
Immunology · 63d
Cleared Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
K990610 · JJY
Bio-Rad
Chemistry · 62d
Cleared Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587 · DHR
Bio-Rad
Immunology · 43d
Cleared Apr 06, 1999
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
K990863 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 21d
Cleared Mar 31, 1999
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
K990424 · JJY
Bio-Rad
Chemistry · 48d