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: Cardiovascular ×
18,182 results
2185–2208 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 27, 2019
Plexus
K191107 · JOW
Alleva Medical (D.G), Ltd.
Cardiovascular · 123d
Cleared Aug 27, 2019
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K191077 · KFM
Medtronic, Inc.
Cardiovascular · 126d
Cleared Aug 23, 2019
Electronic Blood Pressure Monitor
K191180 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 113d
Cleared Aug 23, 2019
EkoSonic Endovascular Device
K191119 · QEY
Btg International, Inc.
Cardiovascular · 119d
Cleared Aug 23, 2019
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
K190593 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 169d
Cleared Aug 23, 2019
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
K190127 · NLH
Innovative Health, LLC
Cardiovascular · 207d
Cleared Aug 22, 2019
BB-613WP
K190792 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 148d
Cleared Aug 22, 2019
Bendit2.7 Steerable Microcatheter
K190126 · DQO
Bend IT Technologies, Ltd.
Cardiovascular · 206d
Cleared Aug 21, 2019
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip...
K191413 · PZX
AtriCure, Inc.
Cardiovascular · 85d
Cleared Aug 19, 2019
Blood Pressure Monitor
K190207 · DXN
Shenzhen Viatom Technology Co., Ltd.
Cardiovascular · 196d
Cleared Aug 15, 2019
HeartFlow FFRct Analysis
K190925 · PJA
HeartFlow, Inc.
Cardiovascular · 128d
Cleared CT Aug 15, 2019
Biovitals Analytics Engine
K183282 · PLB
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 262d
Cleared Aug 14, 2019
Zurich Pressure Guidewire System Model 100
K190852 · DXO
Zurich Medical, Inc.
Cardiovascular · 134d
Cleared Aug 13, 2019
Instylla Microcatheter
K191731 · KRA
Instylla, Inc.
Cardiovascular · 46d
Cleared Aug 09, 2019
Turnpike Catheter
K191560 · DQY
Vascular Solutions, LLC
Cardiovascular · 57d
Cleared CT Aug 09, 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys...
K191114 · PQK
Avenu Medical
Cardiovascular · 105d
Cleared Aug 08, 2019
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
K190716 · LDF
Medtronic
Cardiovascular · 142d
Cleared Aug 07, 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
K191871 · DYB
Boston Scientific Corporation
Cardiovascular · 26d
Cleared Aug 07, 2019
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and...
K191840 · PPN
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared Aug 07, 2019
RenovoCath
K191606 · MJN
Renovorx, Inc.
Cardiovascular · 51d
Cleared Aug 07, 2019
Non-invasive Hemodynamic Blood Pressure Monitor
K190893 · DXN
Vita-Course Technologies Co., Ltd.
Cardiovascular · 124d
Cleared Aug 07, 2019
Revolution Centrifugal Blood Pump
K190650 · KFM
Sorin Group Italia S.R.L.
Cardiovascular · 147d
Cleared Aug 06, 2019
M3290B Patient Information Center iX
K183387 · MHX
Philips Medical Systems
Cardiovascular · 243d
Cleared Aug 06, 2019
EmboCube Embolization Gelatin
K183120 · KRD
Biosphere Medical, S.A.
Cardiovascular · 270d