FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
433–456 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
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