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
1873–1896 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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 Jun 26, 2020
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx...
K193473 · MXD
Boston Scientific Corporation
Cardiovascular · 193d
Cleared Jun 25, 2020
Bendit2.7 Steerable Microcatheter
K200582 · KRA
Bend IT Technologies, Ltd.
Cardiovascular · 111d
Cleared Jun 25, 2020
Blood Pressure Monitor
K200437 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 122d
Cleared Jun 25, 2020
Blood Pressure Monitor
K193348 · DXN
Shenzhen Viatom Technology Co., Ltd.
Cardiovascular · 205d
Cleared Jun 22, 2020
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
K200195 · OBJ
Northeast Scientific, Inc.
Cardiovascular · 147d
Cleared Jun 22, 2020
Zeroveno
K192337 · JOW
Dimedi Co., Ltd.
Cardiovascular · 299d
Cleared Jun 19, 2020
MPS 3 Myocardial Protection System
K200438 · DTR
Quest Medical, Inc.
Cardiovascular · 116d
Cleared Jun 18, 2020
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K200297 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 133d
Cleared Jun 18, 2020
OptoMonitor 3
K193620 · DXO
Opsens, Inc.
Cardiovascular · 175d
Cleared Jun 16, 2020
Koya Ripple
K193288 · JOW
Koya, Inc.
Cardiovascular · 202d
Cleared Jun 15, 2020
Abiomed 23 Fr Sheath
K201116 · DYB
Abiomed, Inc.
Cardiovascular · 49d
Cleared Jun 13, 2020
STERIS Patient Warming System
K200446 · DWJ
STERIS Corporation
Cardiovascular · 110d
Cleared Jun 12, 2020
ExpanSure Large Access Transseptal Dilator
K201288 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 29d
Cleared Jun 12, 2020
INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE...
K200683 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 88d
Cleared Jun 12, 2020
Full Automatic(NIBP) Blood Pressure Monitor
K200521 · DXN
Health & Life Co., Ltd.
Cardiovascular · 102d
Cleared Jun 12, 2020
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
K193379 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 190d
Cleared Jun 11, 2020
physIQ Heart Rhythm and Respiration Module
K193415 · DPS
Physiq, Inc.
Cardiovascular · 185d
Cleared Jun 08, 2020
ePM Series Patient monitors
K200015 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 157d
Cleared Jun 05, 2020
Spire Health Remote Patient Monitoring System
K192952 · MSX
Spire, Inc. D/B/A Spire Health
Cardiovascular · 228d
Cleared Jun 03, 2020
Agilis HisPro Steerable Catheter With Electrodes
K200721 · DQY
Abbott (St. Jude Medical)
Cardiovascular · 76d
Cleared Jun 03, 2020
Cardioblate Gemini-s Surgical Ablation Device
K200514 · OCL
Medtronic
Cardiovascular · 93d
Cleared Jun 03, 2020
pREBOA-PRO Catheter
K200459 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 99d