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

901 results for "Abbott Laboratories"
769–792 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 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
Cleared Apr 21, 1981
INTERFACE 20 MICRON TRANSFUSION BLD. F.
K810855 · CAK
Abbott Laboratories
Hematology · 22d
Cleared Apr 01, 1981
A-GENT UREA NITROGEN
K810794 · CDQ
Abbott Laboratories
Chemistry · 9d
Cleared Mar 17, 1981
QUANTICHECK CONTROL PLASMA
K803081 · GGQ
Abbott Laboratories
Chemistry · 102d
Cleared Feb 26, 1981
HTSH RIABEAD DIAGNOSTIC KIT
K810381 · CGJ
Abbott Laboratories
Chemistry · 13d
Cleared Jan 29, 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Jan 28, 1981
CYBREX VALPROIC ACID
K803236 · LEG
Abbott Laboratories
Toxicology · 36d
Cleared Jan 21, 1981
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
K803219 · GKZ
Abbott Laboratories
Microbiology · 33d