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

79 results for "Abbott Medical"
1–24 of 79
Search insights Median review: 88d Cleared: 100% Top manufacturer: Abbott Medical Lead specialty: Cardiovascular
Cleared Sep 17, 2026
EnSite™ X EP System
K261729 · DQK
Abbott Medical
Cardiovascular · 114d
Cleared Jul 15, 2026
EnSite™ X EP System
K262006 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Jun 17, 2026
Amplatzer TorqVue Exchange System
K261631 · DQY
Abbott Medical
Cardiovascular · 30d
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 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 Oct 29, 2025
Seguin Annuloplasty Ring
K253232 · KRH
Abbott Medical
Cardiovascular · 30d
Cleared Oct 03, 2025
Amplatzer Guidewire
K250031 · DQX
Abbott Medical
Cardiovascular · 269d
Cleared Sep 25, 2025
EnSite™ X EP System
K252013 · DQK
Abbott Medical
Cardiovascular · 90d
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 25, 2025
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K250552 · DQX
Abbott Medical
Cardiovascular · 150d
Cleared May 27, 2025
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841 · GXI
Abbott Medical
Neurology · 250d
Cleared May 23, 2025
ViewFlex™ Xtra ICE Catheter
K251211 · OBJ
Abbott Medical
Cardiovascular · 35d
Cleared May 20, 2025
ViewFlex™ X ICE Catheter, Sensor Enabled™
K251231 · OBJ
Abbott Medical
Cardiovascular · 28d
Cleared Apr 25, 2025
Amulet™ Steerable Delivery Sheath
K250426 · DQY
Abbott Medical
Cardiovascular · 70d
Cleared CT Apr 04, 2025
JETi Hydrodynamic Thrombectomy System
K243549 · QEZ
Abbott Medical
Cardiovascular · 140d
Cleared Dec 31, 2024
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
K243224 · DQY
Abbott Medical
Cardiovascular · 85d
Cleared Dec 13, 2024
Agilis NxT Steerable Introducer Dual-Reach
K243493 · DYB
Abbott Medical
Cardiovascular · 31d
Cleared Nov 06, 2024
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K240997 · DQX
Abbott Medical
Cardiovascular · 209d