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"
49–72 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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 Dec 06, 2024
Alinity m SARS-CoV-2 AMP Kit (09N78-096)
K241580 · QQX
Abbott Molecular
Microbiology · 186d
Cleared Nov 29, 2024
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
K242225 · NLH
Surgical Instrument Service and...
Cardiovascular · 123d
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
Cleared Oct 16, 2024
Alkaline Phosphatase
K240468 · CJE
Abbott Laboratories Diagnostics Division
Chemistry · 239d
Cleared Aug 30, 2024
Alinity i Toxo IgM
K233932 · LGD
Abbott Laboratories
Microbiology · 260d
Cleared Aug 26, 2024
TriClip Steerable Guide Catheter
K241538 · DQY
Abbott Medical
Cardiovascular · 88d
Cleared Aug 09, 2024
EnSite™ X EP System
K242016 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Jul 09, 2024
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
K241372 · MTD
Abbott Medical
Cardiovascular · 55d
Cleared Jun 13, 2024
Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
K241370 · DYB
Abbott Medical
Cardiovascular · 30d
Cleared Jun 07, 2024
Libre Rio Continuous Glucose Monitoring System
K233861 · SBH
Abbott Diabetes Care
Chemistry · 184d
Cleared May 29, 2024
Lingo Glucose System
K233655 · SAF
Abbott
Chemistry · 197d
Cleared May 03, 2024
Alinity m HSV 1 & 2 / VZV
K233349 · PGI
Abbott Molecular, Inc.
Microbiology · 217d
Cleared Apr 23, 2024
FreeStyle Libre 3 Continuous Glucose Monitoring System
K233537 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 172d
Cleared Mar 27, 2024
i-STAT TBI Cartridge with the i-STAT Alinity System
K234143 · QAT
Abbott Point of Care
Immunology · 89d
Cleared Jan 26, 2024
CentriMag™ Acute Circulatory Support System
K234118 · QNR
Abbott Medical
Cardiovascular · 29d
Cleared Dec 19, 2023
JETi™Hydrodynamic Thrombectomy System
K232458 · QEZ
Abbott Medical
Cardiovascular · 126d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300 · JFP
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · CHL
Abbott Point of Care, Inc.
Chemistry · 267d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · JGS
Abbott Point of Care, Inc.
Chemistry · 268d
Cleared Oct 10, 2023
ID NOW Influenza A & B 2
K232775 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 29d
Cleared Sep 29, 2023
Amulet™ Steerable Delivery Sheath
K232690 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Sep 29, 2023
TBI
K232669 · QAT
Abbott Laboratories
Immunology · 28d