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
1681–1704 of 18,110
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 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