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"
1–24 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 23, 2026
Anti-HCV Next
K262156 · MZO
Abbott Laboratories
Microbiology · 89d
Cleared Sep 17, 2026
EnSite™ X EP System
K261729 · DQK
Abbott Medical
Cardiovascular · 114d
Not Cleared Aug 25, 2026
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
DEN250049 · SJD
Abbott Diabetes Care
Chemistry · 330d
Cleared Jul 15, 2026
EnSite™ X EP System
K262006 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Jul 02, 2026
Amplatzer TorqVue LP Delivery System
K261825 · DQY
Abbott
Cardiovascular · 30d
Cleared Jun 26, 2026
i-STAT Crea cartridge with the i-STAT 1 System
K261039 · CGL
Abbott Point of Care, Inc.
Chemistry · 88d
Cleared Jun 17, 2026
Amplatzer TorqVue Exchange System
K261631 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Jun 11, 2026
i-STAT hs-TnI cartridge with the i-STAT Alinity System
K253051 · MMI
Abbott Point of Care, Inc.
Chemistry · 262d
Cleared Apr 28, 2026
Anti-HCV Next
K252424 · MZO
Abbott Laboratories
Microbiology · 270d
Cleared Apr 24, 2026
Amplatzer TorqVue Delivery System
K260993 · DQY
Abbott
Cardiovascular · 29d
Cleared CT Apr 24, 2026
OPTIS Mobile Next Imaging System (1014932)
K253459 · NQQ
Abbott Medical
Cardiovascular · 199d
Cleared Apr 20, 2026
EnSite™ X EP System
K260212 · DQK
Abbott Medical
Cardiovascular · 87d
Cleared Apr 16, 2026
Disposable Radiofrequency Cannula
K253907 · GXI
Abbott Medical
Neurology · 132d
Cleared Mar 13, 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Feb 13, 2026
Armada™ 14 NC PTA Catheter
K252512 · LIT
Abbott Medical
Cardiovascular · 186d
Cleared Dec 19, 2025
Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
K250314 · PNE
Surgical Instrument Service and...
Cardiovascular · 318d
Cleared Dec 18, 2025
Assert-IQ (DM5100)
K253516 · MXD
Abbott Medical
Cardiovascular · 36d
Cleared Dec 17, 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417 · DQY
Abbott Medical
Cardiovascular · 138d
Cleared Dec 01, 2025
IBP cable Becton Dickinson (2606488)
K252827 · DSA
Dr?gerwerk AG & Co KGaA
Cardiovascular · 87d
Cleared Oct 29, 2025
Seguin Annuloplasty Ring
K253232 · KRH
Abbott Medical
Cardiovascular · 30d
Cleared Oct 24, 2025
Glucose2
K252357 · CFR
Abbott Ireland
Chemistry · 87d
Cleared Oct 03, 2025
Amplatzer Guidewire
K250031 · DQX
Abbott Medical
Cardiovascular · 269d
Cleared Sep 30, 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669 · DSA
Shanghai Draeger Medical Instrument...
Cardiovascular · 123d
Cleared Sep 25, 2025
Alinity m HCV
K252102 · MZP
Abbott Molecular, Inc.
Microbiology · 84d