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

Filters:
1,305 results for "abbott"
145–168 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 30, 2020
HI-TORQUE PROCEED Guide Wire Family
K201834 · DQX
Abbott Vascular
Cardiovascular · 28d
Cleared Jun 26, 2020
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
K201181 · DQK
Abbott Medical
Cardiovascular · 57d
Cleared Jun 26, 2020
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software...
K201148 · DQK
Abbott Medical
Cardiovascular · 58d
Cleared Jun 12, 2020
FreeStyle Libre 2 Flash Glucose Monitoring System
K193371 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 190d
Cleared Jun 03, 2020
Agilis HisPro Steerable Catheter With Electrodes
K200721 · DQY
Abbott (St. Jude Medical)
Cardiovascular · 76d
Cleared Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
K200492 · CHL
Abbott Point of Care, Inc.
Chemistry · 41d
Cleared Apr 08, 2020
HI-TORQUE Steelcore Bare Guide Wire
K200144 · DQX
Abbott Vascular
Cardiovascular · 77d
Cleared Mar 17, 2020
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
K193310 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 109d
Cleared Mar 06, 2020
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula...
K200306 · DWA
Abbott (Formerly Thoratec Corporation)
Cardiovascular · 29d
Cleared Feb 28, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183680 · JPI
Abbott Point of Care, Inc.
Hematology · 427d
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · JFP
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · JFL
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · JGS
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · CGA
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Dec 17, 2019
ILUMIEN System with AptiVue Software version D.3
K192267 · DQO
Abbott Medical
Cardiovascular · 118d
Cleared Dec 11, 2019
HI-TORQUE InfilTrac Guide Wire Family
K193126 · DQX
Abbott Vascular
Cardiovascular · 29d
Cleared Nov 08, 2019
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
K192019 · DQO
Abbott Medical
Cardiovascular · 102d
Cleared Oct 18, 2019
Confirm Rx Insertable Cardiac Monitor
K192593 · MXC
Abbott
Cardiovascular · 28d
Cleared Sep 17, 2019
Advisor VL Circular Mapping Catheter, Sensor Enabled
K192037 · DRF
Abbott Medical
Cardiovascular · 49d
Cleared CT Sep 13, 2019
ARCHITECT STAT High Sensitivity Troponin-I
K191595 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 88d
Cleared Jul 25, 2019
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
K191173 · NTE
Abbott Vascular
Cardiovascular · 85d
Cleared Jul 11, 2019
ID NOW Influenza A & B 2
K191534 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 31d
Cleared Jul 10, 2019
CentriMag Acute Circulatory Support System
K191557 · DWA
Thoratec Corporation (Now Part of...
Cardiovascular · 28d
Cleared May 29, 2019
MitraClip G4 Steerable Guide Catheter
K190167 · DRA
Abbott
Cardiovascular · 118d