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"
361–384 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 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
Cleared May 06, 1993
ABBOTT VISION THEOPHYLLINE IIA
K926245 · KLS
Abbott Laboratories
Toxicology · 143d
Cleared Apr 23, 1993
IVEX-HP96 EXTENDED LIFE FILTER SET
K920736 · FPB
Abbott Laboratories
General Hospital · 429d
Cleared Apr 07, 1993
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · FRN
Abbott Laboratories
General Hospital · 259d
Cleared Jan 26, 1993
ABBOTT IMX T4
K925110 · CDX
Abbott Laboratories
Chemistry · 109d
Cleared Jan 13, 1993
IMX PAP
K925377 · JFH
Abbott Laboratories
Chemistry · 82d
Cleared Jan 04, 1993
ABBOTT TDX/TDXFLX TT4
K925109 · CDX
Abbott Laboratories
Chemistry · 87d