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
1945–1968 of 18,110
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 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 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