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"
217–240 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 05, 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531 · NBW
Abbott Laboratories
Chemistry · 95d
Cleared Jun 05, 2015
FreeStyle Lite Blood Glucose Monitoring System
K150332 · NBW
Abbott Laboratories
Chemistry · 115d
Cleared May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · PDJ
Abbott Laboratories
Chemistry · 434d
Cleared May 06, 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
K143434 · MSS
Abbott Medical Optics, Inc.
Ophthalmic · 156d
Cleared Apr 16, 2015
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total...
K133002 · DHA
Abbott Point of Care, Inc.
Chemistry · 569d
Cleared Apr 02, 2015
Total Bilirubin
K150510 · CIG
Abbott Laboratories
Chemistry · 34d
Cleared Dec 19, 2014
Hi-Torque JET Guide Wire Family
K142415 · DQX
Abbott Vascular, Inc.
Cardiovascular · 113d
Cleared Sep 30, 2014
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT),...
K140371 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 228d
Cleared Aug 07, 2014
HI-TORQUE VERSATURN GUIDE WIRE
K141782 · DQX
Abbott Vascular
Cardiovascular · 36d
Cleared Jul 22, 2014
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K141678 · NTE
Abbott Vascular
Cardiovascular · 29d
Cleared May 13, 2014
IMDX HSV-1/2 FOR ABBOTT M2000
K140198 · OQO
Intelligent Medical Devices, Inc.
Microbiology · 106d
Cleared May 09, 2014
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
K140354 · LSL
Abbott Molecular, Inc.
Microbiology · 86d
Cleared Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · PDJ
Abbott Laboratories
Chemistry · 392d
Cleared Feb 27, 2014
COMPACT INTUITIV
K133115 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 150d
Cleared Dec 24, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 134d
Cleared Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235 · OZN
Intelligent Medical Devices, Inc.
Microbiology · 85d
Cleared Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
K131508 · PFG
Abbott Molecular, Inc.
Pathology · 112d
Cleared Aug 21, 2013
IMDX FLU A/B AND RSV FOR ABBOTT M2000
K131584 · OCC
Intelligent Medical Devices, Inc.
Microbiology · 82d
Not Cleared Jul 29, 2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
DEN130010 · PDO
Abbott Molecular, Inc.
Pathology · 111d
Cleared Jul 17, 2013
IMDX VANR FOR ABBOTT M2000
K123753 · NIJ
Intelligent Medical Devices, Inc.
Microbiology · 223d
Cleared Jun 27, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K130094 · NBW
Abbott Diabetes Care
Chemistry · 168d
Cleared Jun 05, 2013
ABBOTT CARBAMAZEPINE ASSAY
K123518 · KLT
Microgenics Corporation
Toxicology · 203d
Cleared Apr 26, 2013
ABBOTT PHENOBARBITAL ASSAY
K123271 · DLZ
Microgenics Corp.
Chemistry · 189d
Cleared Apr 05, 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · NBW
Abbott Laboratories
Chemistry · 186d