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
2017–2040 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 03, 2020
ADAPT Tissue
K200566 · PSQ
Admedus Regen Pty, Ltd.
Cardiovascular · 30d
Cleared Apr 03, 2020
Aria System
K200564 · JOW
Inova Labs
Cardiovascular · 30d
Cleared CT Apr 02, 2020
NovaCross CTO Microcatheter
K193322 · DQY
Nitiloop , Ltd.
Cardiovascular · 122d
Cleared Apr 02, 2020
Patient Monitor
K192514 · MHX
Edan Instruments, Inc.
Cardiovascular · 203d
Cleared Mar 31, 2020
SiteSeal Femoral Compression Device
K192413 · DXC
Ensite Vacular, LLC
Cardiovascular · 209d
Cleared Mar 29, 2020
QuickDraw Venous Cannula
K200499 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Mar 29, 2020
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE...
K200494 · MHX
Ge Healthcare
Cardiovascular · 30d
Cleared Mar 28, 2020
MRI ECG Patient Cable
K192852 · LNH
Ivy Biomedical Systems, Inc.
Cardiovascular · 177d
Cleared Mar 26, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide...
K192886 · DQX
Volcano Corporation
Cardiovascular · 168d
Cleared Mar 26, 2020
BodyGuardian Remote Monitoring System
K192732 · DSI
Preventice Technologies, Inc.
Cardiovascular · 181d
Cleared Mar 25, 2020
Disposable NIBP Cuff
K193629 · DXQ
Shenzhen Changke Connect Electronics...
Cardiovascular · 90d
Cleared Mar 24, 2020
FloPatch (FP120)
K200337 · DPW
Flosonics Medical (R/A 1929803...
Cardiovascular · 42d
Cleared Mar 20, 2020
AI-ECG Tracker
K200036 · DPS
Shenzhen Carewell Electronics Co., Ltd.
Cardiovascular · 72d
Cleared Mar 20, 2020
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
K193183 · OBJ
Acist Medical Systems, Inc.
Cardiovascular · 123d
Cleared Mar 20, 2020
AZUR Vascular Plug
K191680 · KRD
MicroVention, Inc.
Cardiovascular · 270d
Cleared Mar 19, 2020
Super Sheath
K200379 · DRE
Togo Medikit Co., Ltd.
Cardiovascular · 30d
Cleared Mar 19, 2020
Compression Therapy Device
K191856 · JOW
Guangzhou Longest Science &...
Cardiovascular · 252d
Cleared Mar 18, 2020
WIRION
K200198 · NTE
Cardiovascular Systems, Inc.
Cardiovascular · 51d
Cleared Mar 18, 2020
speX LP Support Catheter
K200094 · DQY
Reflow Medical
Cardiovascular · 62d
Cleared Mar 17, 2020
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
K193310 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 109d
Cleared Mar 16, 2020
Sunmed Disposable Angio-Closure Pads
K191827 · DXC
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 252d
Cleared Mar 13, 2020
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula,...
K200358 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared CT Mar 13, 2020
Indigo Aspiration System – Lightning Aspiration Tubing
K193244 · QEW
Penumbra, Inc.
Cardiovascular · 109d
Cleared Mar 09, 2020
Edwards eSheath Introducer Set
K200258 · DYB
Edwards Lifesciences
Cardiovascular · 35d