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
1465–1488 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 24, 2021
Guiding Catheter
K210009 · DQY
CenterPoint Systems, LLC
Cardiovascular · 324d
Cleared Nov 23, 2021
Hypotension Decision Assist Model HDA-OR2
K212529 · DXG
Directed Systems, Ltd.
Cardiovascular · 104d
Cleared Nov 22, 2021
Pre-Formed Extra Support Guidewire
K211741 · DQX
Lake Region Medical
Cardiovascular · 168d
Cleared Nov 22, 2021
Eclipse PRO
K211651 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 178d
Cleared Nov 19, 2021
EkoSonic Endovascular Device
K211080 · QEY
Boston Scientific
Cardiovascular · 221d
Cleared Nov 18, 2021
Cardiologs Holter Platform
K212112 · DPS
Cardiologs Technologies
Cardiovascular · 135d
Cleared Nov 18, 2021
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
K211937 · JOW
Jiangsu Synecoun Medical Technology...
Cardiovascular · 149d
Cleared Nov 18, 2021
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
K211662 · NLG
Innovative Health, LLC
Cardiovascular · 170d
Cleared Nov 18, 2021
Capiox iCP Centrifugal Pump
K200091 · KFM
Terumo Cardiovascular Systems...
Cardiovascular · 672d
Cleared Nov 16, 2021
Pantheris System
K212047 · MCW
Avinger, Inc.
Cardiovascular · 139d
Cleared Nov 15, 2021
Circul8 Pro
K212731 · JOW
Ortho8, Inc.
Cardiovascular · 77d
Cleared Nov 15, 2021
Vital Signs Monitor
K211754 · MWI
Beijing Choice Electronic Technology...
Cardiovascular · 161d
Not Cleared Nov 13, 2021
Hemolung Respiratory Assist System
DEN210006 · QOH
Alung Technologies, Inc.
Cardiovascular · 254d
Cleared Nov 11, 2021
EnSite X EP System
K213364 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Nov 10, 2021
eKuore Pro 4T - REF EP0098
K212013 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 135d
Cleared Nov 10, 2021
ESSENZ Patient Monitor
K212003 · DXJ
Livanova Deutschland, GmbH
Cardiovascular · 135d
Cleared Nov 10, 2021
Venen-trainer (Model: FM150, SFM90)
K203746 · JOW
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 323d
Cleared Nov 09, 2021
Vektor Computational ECG Mapping System (vMap)
K211546 · DQK
Vektor Medical, Inc.
Cardiovascular · 174d
Cleared Nov 09, 2021
RMU-2000 Automated Chest Compression System
K211289 · DRM
Defibtech, LLC
Cardiovascular · 195d
Cleared Nov 08, 2021
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen...
K203067 · DWF
Qura S.R.L
Cardiovascular · 395d
Cleared Nov 04, 2021
Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
K211288 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 190d
Cleared Nov 03, 2021
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
K212199 · QEZ
Merit Medical Systems, Inc.
Cardiovascular · 112d
Cleared Nov 03, 2021
IM007
K210543 · DQK
Implicity, Inc.
Cardiovascular · 252d
Cleared Nov 03, 2021
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
K201320 · KFM
Qura S.R.L
Cardiovascular · 534d