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"
697–720 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 21, 1994
AXSYM ULTRASENSITIVE HTSH
K934410 · JLW
Abbott Laboratories
Chemistry · 284d
Cleared Jun 21, 1994
AXSYM(TM) TOTAL T4
K934384 · CDX
Abbott Laboratories
Chemistry · 293d
Cleared Jun 21, 1994
AXSYM(TM) T-UPTAKE
K934312 · KHQ
Abbott Laboratories
Chemistry · 293d
Cleared Jun 20, 1994
HAND CONTROLLED SYRINGE
K942329 · DQO
Abbott Laboratories
Cardiovascular · 35d
Cleared Jun 13, 1994
DYE MANAGEMENT SYSTEM
K941254 · DQO
Abbott Laboratories
Cardiovascular · 94d
Cleared Jun 09, 1994
ENERGIZED DRUG CONTAINER SYSTEM
K934119 · FPA
Abbott Laboratories
General Hospital · 288d
Cleared Jun 09, 1994
FLEXIFLO GASTROSTOMY KIT
K932861 · KNT
Abbott Laboratories
Gastroenterology & Urology · 363d
Cleared Jun 09, 1994
FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
K925102 · KNT
Abbott Laboratories
Gastroenterology & Urology · 609d
Cleared Mar 28, 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326 · FPA
Abbott Laboratories
General Hospital · 263d
Cleared Mar 28, 1994
ABBOTT SMART CAP
K921818 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 712d
Cleared Mar 14, 1994
HI-FLO INFUSION PUMP
K934671 · FRN
Abbott Laboratories
General Hospital · 166d
Cleared Feb 17, 1994
REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S
K931484 · BZD
Portable Power Systems, Inc.
Anesthesiology · 330d
Cleared Jan 13, 1994
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
K925385 · JIX
Alko Diagnostic Corp.
Chemistry · 444d
Cleared Nov 03, 1993
DYE MANAGEMENT SYSTEM
K933700 · DQO
Abbott Laboratories
Cardiovascular · 97d
Cleared Nov 03, 1993
ENERGIZED CONTAINER SYSTEM
K925418 · FPA
Abbott Laboratories
General Hospital · 372d
Cleared Oct 25, 1993
SAFESET RESERVOIR
K932188 · KRA
Abbott Laboratories
Cardiovascular · 172d
Cleared Oct 08, 1993
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · KNT
Abbott Laboratories
Gastroenterology & Urology · 372d
Cleared Sep 01, 1993
ABBOTT PLUM XL INFUSION PUMP
K931375 · FRN
Abbott Laboratories
General Hospital · 167d
Cleared Aug 27, 1993
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
K924697 · KNT
Abbott Laboratories
Gastroenterology & Urology · 344d
Cleared Aug 09, 1993
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
K932127 · LGS
Abbott Laboratories
Hematology · 98d
Cleared Jul 14, 1993
TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
K932615 · LAO
Abbott Laboratories
Toxicology · 43d
Cleared Jul 14, 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · GKZ
Abbott Laboratories
Hematology · 174d
Cleared Jun 16, 1993
ABBOTT IMX2 ANALYER
K931970 · JJI
Abbott Laboratories
Chemistry · 55d
Cleared Jun 15, 1993
IMX(R) STAT CK-MB
K931172 · JHY
Abbott Laboratories
Chemistry · 99d