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
1537–1560 of 18,182
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 CT 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 CT 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