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
1129–1152 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 15, 2023
Arm Blood Pressure Monitor
K222869 · DXN
Andon Health Co, Ltd.
Cardiovascular · 146d
Cleared Feb 15, 2023
ZEUS System
K222389 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 191d
Cleared Feb 13, 2023
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K223186 · QEW
Penumbra, Inc.
Cardiovascular · 124d
Cleared Feb 06, 2023
Care Team Portal
K222398 · DRG
Vivify Health, Inc.
Cardiovascular · 182d
Cleared Feb 06, 2023
ClotTriever Thrombectomy System
K221531 · QEW
Inari Medical, Inc.
Cardiovascular · 256d
Cleared Feb 03, 2023
14F iSLEEVE™ Introducer Set
K230051 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Feb 03, 2023
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K223026 · OWQ
Northeast Scientific, Inc.
Cardiovascular · 127d
Cleared Feb 03, 2023
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular...
K222153 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 198d
Cleared Feb 03, 2023
Anivia SG1000 Pump Console
K221491 · DWA
Apmtd, Inc.
Cardiovascular · 256d
Cleared Feb 03, 2023
IntelliVue Patient Monitor MX750 (866471)
K221348 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 270d
Cleared Jan 21, 2023
VX1+
K223516 · DQK
Volta Medical
Cardiovascular · 60d
Cleared Jan 20, 2023
Highlander™ 014 PTA Balloon Dilatation Catheter
K223177 · LIT
C.R. Bard, Inc.
Cardiovascular · 101d
Cleared Jan 20, 2023
Capiflo 5001
K222158 · JOW
K&L Distributing, Inc.
Cardiovascular · 184d
Cleared Jan 19, 2023
Low Profile Companion Sheath
K223872 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Jan 19, 2023
Medaica M1 Telehealth Stethoscope
K223166 · DQD
Medaica, Inc.
Cardiovascular · 104d
Cleared Jan 19, 2023
Tunnel Crossing Catheter
K221163 · PDU
Tractus Vascular, LLC
Cardiovascular · 272d
Cleared Jan 12, 2023
Garmin ECG App
K221774 · QDA
Garmin International, Inc.
Cardiovascular · 205d
Cleared Jan 11, 2023
Artix BG
K223000 · QEW
Inari Medical
Cardiovascular · 105d
Cleared Jan 06, 2023
CSF-3
K221260 · DPS
Cardiacsense
Cardiovascular · 249d
Cleared Jan 06, 2023
T3 Platform software
K213423 · PLB
Etiometry, Inc.
Cardiovascular · 443d
Cleared Jan 04, 2023
Radial Artery Compression Tourniquets
K222182 · DXC
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 166d
Cleared Dec 30, 2022
Biobeat Platform-2 and BB-613WP Patch
K222010 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 176d
Cleared Dec 30, 2022
Isolator® Linear Pen (MLP1)
K221358 · OCL
AtriCure, Inc.
Cardiovascular · 233d
Cleared Dec 30, 2022
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
K210313 · DRF
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 695d