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"
169–192 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 10, 2019
Confirm Rx Insertable Cardiac Monitor
K190295 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 58d
Cleared Apr 05, 2019
Amplatzer Trevisio Intravascular Delivery System
K190581 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Apr 02, 2019
Ilumien Optis, Optis Integrated, Optis Mobile
K183320 · NQQ
St. Jude Medical (Now Abbott Medical)
Cardiovascular · 123d
Cleared Mar 29, 2019
Confirm Rx Insertable Cardiac Monitor
K182981 · MXC
Abbott
Cardiovascular · 151d
Cleared Mar 15, 2019
CELL-DYN Emerald 22 AL System
K190294 · GKZ
Abbott Laboratories
Hematology · 32d
Cleared Feb 28, 2019
QUANTIEN Measurement System
K183099 · DQK
St. Jude Medical (Now Abbott Medical)
Cardiovascular · 113d
Cleared Dec 12, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
K183128 · DQK
Abbott
Cardiovascular · 29d
Cleared Oct 19, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
K182644 · DQK
Abbott
Cardiovascular · 25d
Cleared Sep 12, 2018
Magnesium
K181748 · JGJ
Abbott Laboratories
Chemistry · 72d
Cleared Aug 24, 2018
NC TREK™ RX Coronary Dilatation Catheter
K180040 · LOX
Abbott Vascular
Cardiovascular · 231d
Cleared May 18, 2018
Magnesium
K173294 · JGJ
Abbott Laboratories
Chemistry · 214d
Cleared Mar 28, 2018
PressureWire X
K180558 · DXO
St. Jude Medical (Now Part of Abbott...
Cardiovascular · 27d
Cleared Jan 12, 2018
HI-TORQUE TurnTrac Guide Wire Family
K173795 · DQX
Abbott Vascular
Cardiovascular · 29d
Cleared Nov 21, 2017
Alere Afinion HbA1c and ACR on Afinion 2 analyzer
K171650 · LCP
Abbott Rapid Diagnostics
Chemistry · 169d
Cleared Nov 01, 2017
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short...
K162812 · FPA
Unomedical A/S
General Hospital · 391d
Cleared Oct 27, 2017
Abbott Architect Free T4
K173122 · CEC
Abbott Laboratories
Chemistry · 28d
Cleared Oct 24, 2017
Alinity c ICT Sample Diluent
K170320 · CGZ
Abbott Laboratories
Chemistry · 265d
Cleared Oct 23, 2017
Alinity i Total ß-hCG Reagent Kit, Alinity i System
K170317 · DHA
Abbott Laboratories
Chemistry · 264d
Cleared Oct 19, 2017
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · CFR
Abbott Laboratories
Chemistry · 260d
Cleared Sep 27, 2017
FreeStyle Precision Neo Blood Glucose Test Strips
K171941 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 91d
Cleared Sep 06, 2017
Steerable Guide Catheter
K172394 · DRA
Abbott Vascular
Cardiovascular · 29d
Cleared Sep 01, 2017
RhythmView Workstation
K171583 · DQK
Abbott Electrophysiology
Cardiovascular · 93d
Cleared Aug 25, 2017
Hi-Torque Command 18 Guide Wire
K172073 · DQX
Abbott Vascular
Cardiovascular · 46d
Cleared Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
K163342 · JPI
Abbott Laboratories
Hematology · 266d