FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
2113–2136 of 18,110
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 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 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