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"
433–456 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 11, 2002
MODIFICATION TO SUPERCROSS CATHETER
K014118 · DQY
Abbott Vascular, Inc.
Cardiovascular · 28d
Cleared Dec 14, 2001
ETHANOL
K013538 · DML
Abbott Laboratories
Toxicology · 51d
Cleared Dec 06, 2001
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
K013683 · GAW
Abbott Vascular, Inc.
General & Plastic Surgery · 29d
Cleared Dec 05, 2001
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
K012014 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 176d
Cleared Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · GKZ
Abbott Laboratories
Hematology · 28d
Cleared Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
K011853 · JJY
Bio-Rad
Immunology · 34d
Cleared Jun 18, 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
K010553 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Jun 12, 2001
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 256d
Cleared Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
K010953 · GKZ
Abbott Laboratories
Hematology · 68d
Cleared Jun 05, 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · FRN
Abbott Laboratories
General Hospital · 26d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH...
K011217 · DQO
Abbott Laboratories
Cardiovascular · 26d
Cleared May 09, 2001
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
K011077 · KNT
Andersen Products, Inc.
Gastroenterology & Urology · 30d
Cleared May 01, 2001
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared Apr 06, 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Mar 07, 2001
SUPERCROSS CATHETER
K001856 · DQY
Abbott Vascular, Inc.
Cardiovascular · 261d
Cleared Jan 08, 2001
STERILE PISTON SYRINGE
K002717 · FMF
Abbott Laboratories
General Hospital · 130d
Cleared Dec 05, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
K000582 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 287d
Cleared Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · LFR
Abbott Laboratories
Chemistry · 137d
Cleared Oct 05, 2000
SPIROL EPIDURAL CATHETER
K000886 · BSO
Abbott Laboratories
Anesthesiology · 199d
Cleared Oct 03, 2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
K001703 · GAW
Abbott Vascular, Inc.
General & Plastic Surgery · 120d
Cleared Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · FPA
Abbott Laboratories
General Hospital · 38d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616 · FOZ
Abbott Laboratories
General Hospital · 63d
Cleared Jul 20, 2000
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · FRN
Abbott Laboratories
General Hospital · 6d
Cleared May 25, 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · LCP
Abbott Laboratories
Hematology · 339d