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
1945–1968 of 18,182
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