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

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1,305 results for "abbott"
73–96 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 27, 2023
Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
K214117 · LCP
Abbott Diagnostics Technologies AS
Chemistry · 636d
Cleared Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · CHL
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Sep 11, 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · CGA
Abbott Point of Care, Inc.
Chemistry · 270d
Cleared Sep 08, 2023
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with...
K232386 · NQQ
Abbott Medical
Cardiovascular · 30d
Cleared Aug 10, 2023
EnSite™ X EP System
K231415 · DQK
Abbott Medical
Cardiovascular · 86d
Cleared Aug 10, 2023
HAVAb IgG II
K222850 · LOL
Abbott Laboratories
Microbiology · 323d
Cleared Aug 10, 2023
ID NOW COVID-19 2.0
K221925 · QWR
Abbott Diagnostics Scarborough, Inc.
Microbiology · 405d
Cleared Aug 04, 2023
Alinity h-series System
K220031 · GKZ
Abbott Laboratories
Hematology · 576d
Cleared Jul 28, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · CGA
Abbott Point of Care, Inc.
Chemistry · 228d
Cleared Jul 21, 2023
Alkaline Phosphatase2
K223317 · CJE
Abbott Ireland Diagnostics Division
Chemistry · 266d
Cleared Jul 14, 2023
i-STAT PTplus Cartridge with the i-STAT 1 System
K220282 · GJS
Abbott Laboratories
Hematology · 528d
Cleared Jun 30, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K231588 · OWQ
Abbott Medical
Cardiovascular · 29d
Cleared Jun 05, 2023
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
K230937 · DHA
Abbott Laboratories
Chemistry · 63d
Cleared Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
K231311 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared May 19, 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c...
K230790 · DHA
Abbott Laboratories
Chemistry · 58d
Cleared May 17, 2023
Assert-IQ™ Insertable Cardiac Monitor
K230286 · MXC
Abbott Medical
Cardiovascular · 104d
Cleared May 04, 2023
Alinity i STAT High Sensitivity Troponin-I
K230994 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 27d
Cleared May 03, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · OWQ
Abbott Medical
Cardiovascular · 30d
Cleared Apr 14, 2023
Dragonfly OpStar™ Imaging Catheter
K230411 · DQO
Abbott Medical
Cardiovascular · 58d
Cleared Apr 13, 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System
K223435 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 150d
Cleared CT Mar 03, 2023
FreeStyle Libre 2 Flash Glucose Monitoring System
K222447 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 200d
Cleared Mar 03, 2023
Alinity m STI Assay
K222379 · QEP
Abbott Molecular, Inc.
Microbiology · 210d
Cleared Mar 02, 2023
Traumatic brain injury (TBI) test
K223602 · QAT
Abbott Laboratories
Immunology · 90d
Cleared Mar 01, 2023
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120,...
K230283 · DYB
Abbott Medical
Cardiovascular · 28d