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"
97–120 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 07, 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006,...
K040667 · FGE
Abbott Laboratories
Gastroenterology & Urology · 23d
Cleared Mar 25, 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · NBW
Abbott Laboratories
Chemistry · 15d
Cleared Feb 17, 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909 · FGE
Abbott Laboratories
Gastroenterology & Urology · 62d
Cleared Jan 29, 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · FRN
Abbott Laboratories
General Hospital · 9d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · NBW
Abbott Laboratories
Chemistry · 28d
Cleared Dec 10, 2003
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006,...
K033537 · FGE
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Dec 04, 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE,...
K033576 · FPA
Abbott Laboratories
General Hospital · 21d
Cleared Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458 · JIT
Abbott Laboratories
Chemistry · 56d
Cleared Jul 02, 2003
C-REACTIVE PROTEIN (CRP)
K030899 · DCN
Abbott Laboratories
Chemistry · 100d
Cleared May 20, 2003
ROSS EMBRACE ENTERAL PUMP
K031407 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 15d
Cleared May 12, 2003
CELL-DYN 1800 SYSTEM
K030513 · GKZ
Abbott Laboratories
Hematology · 82d
Cleared Apr 30, 2003
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · FRN
Abbott Laboratories
General Hospital · 15d
Cleared Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD...
K023256 · NBW
Abbott Laboratories
Chemistry · 205d
Cleared Jan 27, 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002 · FPA
Abbott Laboratories
General Hospital · 25d
Cleared Jan 15, 2003
RHEUMATOID FACTOR (RF)
K024067 · DHR
Abbott Laboratories
Immunology · 36d
Cleared Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126 · DQO
Abbott Laboratories
Cardiovascular · 29d
Cleared Jan 13, 2003
CHEMO DISPENSING PIN, MODEL 12495
K024239 · LHI
Abbott Laboratories
General Hospital · 21d
Cleared Dec 31, 2002
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · FRN
Abbott Laboratories
General Hospital · 20d
Cleared Dec 26, 2002
MODIFICATION TO ALKP
K023807 · CJE
Abbott Laboratories
Chemistry · 42d
Cleared Dec 16, 2002
ABBOTT ARCHITECT FOLATE
K023397 · CGN
Abbott Laboratories
Chemistry · 68d
Cleared Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE...
K022941 · LFR
Abbott Laboratories
Chemistry · 55d
Cleared Sep 30, 2002
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
K023062 · FRN
Abbott Laboratories, Inc.
General Hospital · 14d
Cleared Sep 13, 2002
TOTAL BILIRUBIN
K022339 · CIG
Abbott Laboratories
Chemistry · 57d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM...
K022182 · NBW
Abbott Laboratories
Chemistry · 68d