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"
1153–1176 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 22, 1982
VENOSET DUAL-RATE PIGGYBACK W/IVEX &
K821578 · FPA
Abbott Laboratories
General Hospital · 25d
Cleared Jun 09, 1982
VENTED NITROGLYCERIN I.V. SET
K821515 · FPA
Abbott Laboratories
General Hospital · 20d
Cleared May 13, 1982
TDX TM STREPTOMYCIN
K821136 · LEH
Abbott Laboratories
Hematology · 23d
Cleared Mar 11, 1982
ABBOTT LABORATORIES B-HCG EIA
K820271 · JHI
Abbott Laboratories
Chemistry · 37d
Cleared Feb 05, 1982
TDX DIGOXIN
K820154 · LCS
Abbott Laboratories
Toxicology · 17d
Cleared Jan 22, 1982
TDX PRIMIDONE
K813597 · DJD
Abbott Laboratories
Chemistry · 25d
Cleared Jan 19, 1982
ABBOTT PAP-EIA
K812925 · JFH
Abbott Laboratories
Chemistry · 92d
Cleared Dec 17, 1981
MS-2 BACTERIAL IDENTIFICATION SYS
K813031 · JTO
Abbott Laboratories
Microbiology · 50d
Cleared Dec 08, 1981
TDX VANCOMYCIN
K813218 · LEH
Abbott Laboratories
Toxicology · 29d
Cleared Nov 10, 1981
QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · JJQ
Abbott Laboratories
Chemistry · 28d
Cleared Nov 06, 1981
ALT-QUANTICHROM
K812926 · CKA
Abbott Laboratories
Chemistry · 18d
Cleared Nov 02, 1981
PEDIATRIC MICROAGGREGATE BLOOD FILTER
K812874 · CAK
Abbott Laboratories
General Hospital · 19d
Cleared Oct 08, 1981
HEMA 20 MICRON TRANSFUSION BLOOD FILTER
K812697 · CAK
Abbott Laboratories
General Hospital · 16d
Cleared Aug 20, 1981
LIFECARE 1000 CONTROLLER
K812114 · LDR
Abbott Laboratories
General Hospital · 24d
Cleared Jul 28, 1981
GASTRIN RIA DIAGNOSTIC KIT
K812004 · CGC
Abbott Laboratories
Chemistry · 14d
Cleared Jul 27, 1981
A-GENT THEOPHYLLINE
K812003 · KLS
Abbott Laboratories
Chemistry · 13d
Cleared Jul 23, 1981
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
K812078 · JTY
Abbott Laboratories
Microbiology
Cleared Jul 02, 1981
RESIDENT BEDSIDE MONITOR
K811216 · DRT
Abbott Laboratories
Cardiovascular · 59d
Cleared Jun 09, 1981
CELL DYN 800 HEMATOLOGY ANALYZER
K803218 · GKL
Abbott Diagnostics
Hematology · 173d
Cleared May 29, 1981
TOX TM ANALYZER
K811263 · JQZ
Abbott Laboratories
Immunology · 23d
Cleared May 29, 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239 · FPA
Abbott Laboratories
General Hospital · 121d
Cleared May 27, 1981
NITROGLYCERINE IV SET
K810317 · FPA
Abbott Laboratories
General Hospital · 110d
Cleared May 05, 1981
RUBAZYME - M
K810835 · GOK
Abbott Laboratories
Immunology · 41d
Cleared Apr 29, 1981
ENTERNAL PUMP SET W/INTEGRAL CONTAINER
K810996 · KNT
Abbott Laboratories
Gastroenterology & Urology · 15d