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"
409–432 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · LFR
Abbott Laboratories
Chemistry · 63d
Cleared Aug 01, 2002
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · MEA
Abbott Laboratories
General Hospital · 27d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874 · DXG
Abbott Laboratories
Cardiovascular · 35d
Cleared Jun 11, 2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
K020866 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 85d
Cleared May 14, 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · FRN
Abbott Laboratories
General Hospital · 15d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K020349 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING...
K020348 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared Mar 20, 2002
PROPOXYPHENE
K013100 · JXN
Abbott Laboratories
Toxicology · 184d
Cleared Mar 20, 2002
METHADONE
K013001 · DJR
Abbott Laboratories
Toxicology · 195d
Cleared Mar 20, 2002
BARBITURATES
K012996 · DIS
Abbott Laboratories
Toxicology · 195d
Cleared Mar 13, 2002
OPIATES
K013314 · DJG
Abbott Laboratories
Toxicology · 160d
Cleared Mar 13, 2002
CANNABINOIDS
K013247 · LDJ
Abbott Laboratories
Toxicology · 166d
Cleared Mar 13, 2002
BENZODIAZEPINES
K013143 · JXM
Abbott Laboratories
Toxicology · 174d
Cleared Mar 13, 2002
PHENCYCLIDINE
K013096 · LCM
Abbott Laboratories
Toxicology · 177d
Cleared Mar 13, 2002
COCAINE
K013004 · DIO
Abbott Laboratories
Toxicology · 188d
Cleared Mar 13, 2002
AMPHETAMINE/METHAMPHETAMINE
K012998 · LAF
Abbott Laboratories
Toxicology · 188d
Cleared Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · NBW
Abbott Laboratories
Chemistry · 176d
Cleared Feb 26, 2002
RUSCH MILLER-ABBOTT TUBE
K010797 · KNT
Rusch Intl.
Gastroenterology & Urology · 347d
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