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"
49–72 of 79
Search insights Median review: 88d Cleared: 100% Top manufacturer: Abbott Medical Lead specialty: Cardiovascular
Cleared Sep 27, 2021
Amplatzer Talisman Delivery Sheath
K212738 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Sep 27, 2021
Amplatzer Steerable Delivery Sheath
K212026 · DQY
Abbott Medical
Cardiovascular · 90d
Cleared Jul 27, 2021
Aveir Introducer
K211989 · DYB
Abbott Medical
Cardiovascular · 29d
Cleared Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458 · NQQ
Abbott Medical
Cardiovascular · 112d
Cleared Nov 25, 2020
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled,...
K202066 · DQK
Abbott Medical
Cardiovascular · 121d
Cleared Oct 21, 2020
IonicRF Generator
K201610 · GXD
Abbott Medical
Neurology · 128d
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 Dec 17, 2019
ILUMIEN System with AptiVue Software version D.3
K192267 · DQO
Abbott Medical
Cardiovascular · 118d
Cleared Nov 08, 2019
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
K192019 · DQO
Abbott Medical
Cardiovascular · 102d
Cleared Sep 17, 2019
Advisor VL Circular Mapping Catheter, Sensor Enabled
K192037 · DRF
Abbott Medical
Cardiovascular · 49d
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 Feb 28, 2019
QUANTIEN Measurement System
K183099 · DQK
St. Jude Medical (Now Abbott Medical)
Cardiovascular · 113d
Cleared Mar 28, 2018
PressureWire X
K180558 · DXO
St. Jude Medical (Now Part of Abbott...
Cardiovascular · 27d
Cleared Aug 18, 2017
QUANTIEN Measurement System
K172182 · DQK
St. Jude Medical (Now Part of the...
Cardiovascular · 30d
Cleared May 19, 2017
Catalys Precision Laser System
K170322 · OOE
Abbott Medical Optics, Inc.
Ophthalmic · 107d
Cleared Apr 27, 2016
Dual Pump Pack
K160236 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 86d
Cleared Oct 19, 2015
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature...
K151636 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 124d
Cleared Sep 02, 2015
COMPACT INTUITIV Multiple-Use Pack
K151783 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 63d
Cleared May 06, 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
K143434 · MSS
Abbott Medical Optics, Inc.
Ophthalmic · 156d
Cleared Feb 27, 2014
COMPACT INTUITIV
K133115 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 150d
Cleared Oct 15, 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
K121721 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 125d
Cleared CT Mar 08, 2012
IFS LASER SYSTEM
K113151 · GEX
Abbott Medical Optics, Inc.
General & Plastic Surgery · 135d