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"
745–768 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 19, 1992
ABBOTT SMART CAP
K915304 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 90d
Cleared Feb 18, 1992
IMX ESTRADIOL
K920047 · CHP
Abbott Laboratories
Chemistry · 43d
Cleared Feb 07, 1992
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
K913958 · LZH
Abbott Laboratories
General Hospital · 155d
Cleared Jan 15, 1992
ABBOTT QUICKSTART TIGLYCERIDES REAGENT
K915732 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jan 15, 1992
IVEX-TPN EXTENSION FILTER SET
K913308 · FPB
Abbott Laboratories
General Hospital · 174d
Cleared Jan 08, 1992
VACUTAINER KIT
K914901 · GIM
Abbott Laboratories
Chemistry · 68d
Cleared Jan 03, 1992
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
K914463 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Dec 19, 1991
PROVIDER APM INFUSION PUMP
K914349 · FRN
Abbott Laboratories
General Hospital · 83d
Cleared Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 131d
Cleared Dec 13, 1991
LIFESHIELD EXTENSION SET
K912103 · FPK
Abbott Laboratories
General Hospital · 214d
Cleared Nov 29, 1991
ABBOTT MATRIX AERO PLUS SYSTEM
K913150 · DHB
Abbott Laboratories
Immunology · 136d
Cleared Nov 29, 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · LGD
Abbott Laboratories
Microbiology · 140d
Cleared Nov 22, 1991
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Nov 22, 1991
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
K914018 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Nov 22, 1991
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K913921 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Nov 05, 1991
FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
K913786 · KNT
Abbott Laboratories
Gastroenterology & Urology · 74d
Cleared Nov 05, 1991
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
K913764 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Oct 31, 1991
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
K912807 · JFY
Em Diagnostic Systems, Inc.
Chemistry · 128d
Cleared Oct 30, 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 25, 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Oct 21, 1991
ABBOTT QUICKSTART LD-1,#5A30
K914261 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 11, 1991
ABBOTT QUICKSTART LDH,#5A31
K914262 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 18d