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"
121–144 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 06, 2002
DIRECT BILIRUBIN
K022180 · CIG
Abbott Laboratories
Chemistry · 65d
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · LFR
Abbott Laboratories
Chemistry · 63d
Cleared Aug 01, 2002
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · MEA
Abbott Laboratories
General Hospital · 27d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874 · DXG
Abbott Laboratories
Cardiovascular · 35d
Cleared May 14, 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · FRN
Abbott Laboratories
General Hospital · 15d
Cleared Mar 20, 2002
PROPOXYPHENE
K013100 · JXN
Abbott Laboratories
Toxicology · 184d
Cleared Mar 20, 2002
METHADONE
K013001 · DJR
Abbott Laboratories
Toxicology · 195d
Cleared Mar 20, 2002
BARBITURATES
K012996 · DIS
Abbott Laboratories
Toxicology · 195d
Cleared Mar 13, 2002
OPIATES
K013314 · DJG
Abbott Laboratories
Toxicology · 160d
Cleared Mar 13, 2002
CANNABINOIDS
K013247 · LDJ
Abbott Laboratories
Toxicology · 166d
Cleared Mar 13, 2002
BENZODIAZEPINES
K013143 · JXM
Abbott Laboratories
Toxicology · 174d
Cleared Mar 13, 2002
PHENCYCLIDINE
K013096 · LCM
Abbott Laboratories
Toxicology · 177d
Cleared Mar 13, 2002
COCAINE
K013004 · DIO
Abbott Laboratories
Toxicology · 188d
Cleared Mar 13, 2002
AMPHETAMINE/METHAMPHETAMINE
K012998 · LAF
Abbott Laboratories
Toxicology · 188d
Cleared Feb 28, 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · NBW
Abbott Laboratories
Chemistry · 176d
Cleared Dec 14, 2001
ETHANOL
K013538 · DML
Abbott Laboratories
Toxicology · 51d
Cleared Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · GKZ
Abbott Laboratories
Hematology · 28d
Cleared Jun 18, 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
K010553 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Jun 12, 2001
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 256d
Cleared Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
K010953 · GKZ
Abbott Laboratories
Hematology · 68d
Cleared Jun 05, 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · FRN
Abbott Laboratories
General Hospital · 26d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH...
K011217 · DQO
Abbott Laboratories
Cardiovascular · 26d
Cleared May 01, 2001
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared Apr 06, 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · FRN
Abbott Laboratories
General Hospital · 10d