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
1753–1776 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 26, 2021
ASI Plethysmogrpah Analyzer
K200567 · JOM
Arterial Stiffness, Inc.
Cardiovascular · 359d
Cleared Feb 24, 2021
Triever Catheters
K210195 · QEW
Inari Medical
Cardiovascular · 30d
Cleared CT Feb 23, 2021
ClotTriever Thrombectomy System
K210190 · QEW
Irani Medical, Inc.
Cardiovascular · 29d
Cleared Feb 22, 2021
COBRA-OS Kit
K201652 · MJN
Front Line Medical Technologies, Inc.
Cardiovascular · 249d
Cleared Feb 18, 2021
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
K201720 · DQX
Beijing Bywave Sensing Medical...
Cardiovascular · 240d
Cleared Feb 17, 2021
VIOLA
K203307 · DXC
Vascular Graft Solutions, Ltd.
Cardiovascular · 100d
Cleared Feb 16, 2021
Extra Large Check-Flo Introducer
K203670 · DYB
Cook Incorporated
Cardiovascular · 62d
Cleared Feb 15, 2021
740 SafeSAT
K200160 · MWI
Zoe Medical, Inc.
Cardiovascular · 390d
Cleared Feb 11, 2021
CATSmart, Automated Blood Processing Autotransfusion System
K210089 · CAC
Fresenius Kabi AG
Cardiovascular · 29d
Cleared Feb 11, 2021
Ezlymph, Ezlymph M
K193662 · JOW
Eezcare Medical Corp
Cardiovascular · 408d
Cleared Feb 10, 2021
Meditech ABPM-06 (BP6)
K201332 · DXN
Meditech , Ltd.
Cardiovascular · 267d
Cleared Feb 09, 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7,...
K210083 · QEW
Penumbra, Inc.
Cardiovascular · 28d
Cleared Feb 09, 2021
Concerto Versa, Detachable Coil
K202850 · KRD
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 134d
Cleared Feb 06, 2021
MouthLab Vital Signs Monitoring System
K201635 · MWI
Multisensor Diagnostics (Dba Aidar...
Cardiovascular · 235d
Cleared Feb 05, 2021
Carnation Ambulatory Monitor (CAM)
K210036 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Feb 05, 2021
Patient Monitoring Cables
K203635 · DSA
Jkh USA, LLC
Cardiovascular · 53d
Cleared Jan 28, 2021
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
K202892 · MWI
Edan Instruments, Inc.
Cardiovascular · 122d
Cleared Jan 28, 2021
Michler-Kapp Cardiovascular Vent Catheter
K200289 · DWF
Kapp Surgical Instrument, Inc.
Cardiovascular · 358d
Cleared Jan 27, 2021
Arm Electronic Sphygmomanometer
K193387 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 27, 2021
Wrist Electronic Sphygmomanometer
K193386 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 26, 2021
VASOBand Vascular Compression Device
K203803 · DXC
Vasoinnovations, Inc.
Cardiovascular · 29d
Cleared Jan 26, 2021
Blood Pressure Monitor
K202934 · DXN
Bioland Technology, Ltd.
Cardiovascular · 119d
Cleared Jan 23, 2021
Patient Monitor
K202336 · MHX
Edan Instruments, Inc.
Cardiovascular · 159d
Cleared Jan 22, 2021
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000...
K203131 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 95d