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"
25–48 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
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 Jul 09, 2025
ARCHITECT iGentamicin
K243500 · LCD
Abbott Laboratories
Toxicology · 239d
Cleared Jul 01, 2025
Alinity m CMV
K243485 · PAB
Abbott Molecular, Inc.
Microbiology · 235d
Cleared Jun 20, 2025
Alinity i Rubella IgG
K243168 · LFX
Abbott Laboratories
Microbiology · 263d
Cleared Jun 13, 2025
BinaxNOW COVID-19 Ag Card
K250273 · QVF
Abbott Diagnostics Scarborough, Inc.
Microbiology · 134d
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 May 02, 2025
i-STAT CG4+ cartridge with the i-STAT 1 System
K244014 · CHL
Abbott Point of Care, Inc.
Chemistry · 127d
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 Mar 24, 2025
Alinity m BKV
K241921 · QMI
Abbott Molecular, Inc.
Microbiology · 266d
Cleared Feb 20, 2025
Alinity h-series System
K243283 · GKZ
Abbott Laboratories
Hematology · 126d
Cleared Feb 14, 2025
Alinity m Resp-4-Plex
K241573 · QOF
Abbott Molecular, Inc.
Microbiology · 256d
Cleared Feb 11, 2025
BinaxNOW™ COVID-19 Antigen Self Test
K243518 · QYT
Abbott Diagnostics Scarborough, Inc.
Microbiology · 90d
Cleared Feb 10, 2025
Calcium2
K244042 · CJY
Abbott Ireland
Chemistry · 42d
Cleared Jan 30, 2025
simpli-COLLECT STI Test
K243410 · QYA
Abbott Molecular
Microbiology · 90d
Cleared Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
K241176 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
Cleared Jan 03, 2025
i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · MMI
Abbott Point of Care, Inc.
Chemistry · 268d