FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
1–24 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 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
Cleared Sep 25, 2025
EnSite™ X EP System
K252013 · DQK
Abbott Medical
Cardiovascular · 90d
Cleared Sep 17, 2025
Assert-IQ (DM5000)
K251221 · MXD
Abbott
Cardiovascular · 149d
Cleared Sep 04, 2025
EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01)
K251463 · DQK
Abbott Medical
Cardiovascular · 115d
Cleared Jul 30, 2025
EnSite™ X EP System
K251234 · DQK
Abbott Medical
Cardiovascular · 99d
Cleared Jul 28, 2025
Alinity m EBV (09N43-095)
K243489 · QLX
Abbott Molecular, Inc.
Microbiology · 258d