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
2881–2904 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 26, 2017
T3 Software
K163065 · MWI
Etiometry, Inc.
Cardiovascular · 205d
Cleared May 26, 2017
Masimo O3 Regional Oximeter System
K162603 · MUD
Masimo Corporation
Cardiovascular · 249d
Cleared May 26, 2017
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing...
K162448 · DQO
Cook Incorporated
Cardiovascular · 267d
Cleared May 25, 2017
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
K171253 · LDF
Medtronic
Cardiovascular · 27d
Cleared May 24, 2017
Central Monitoring System
K170514 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 92d
Cleared May 24, 2017
RA-308 Excimer Laser System, Excimer Laser Catheter
K170349 · PDU
Ra Medical Systems,Inc
Cardiovascular · 110d
Cleared May 24, 2017
INDIGO Aspiration System
K163618 · QEX
Penumbra, Inc.
Cardiovascular · 153d
Cleared May 24, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K163172 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 191d
Cleared May 24, 2017
Matrix Data Management System
K162463 · DXN
Global Instrumentation, LLC
Cardiovascular · 264d
Cleared May 19, 2017
Eko Model E5 System (EME5), Eko DUO
K170874 · DQD
Eko Devices, Inc.
Cardiovascular · 56d
Cleared May 18, 2017
Supreme and Response Electrophysiology Catheters
K161272 · NLH
Surgical Instrument Service and...
Cardiovascular · 378d
Cleared May 17, 2017
Surefire Precision Infusion System
K171355 · DQO
Surefire Medical, Inc.
Cardiovascular · 8d
Cleared May 17, 2017
Cardiac Trigger Monitor
K170828 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 58d
Cleared May 17, 2017
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
K170196 · DXN
A&D Company, Ltd.
Cardiovascular · 114d
Cleared May 16, 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · KRA
Boston Scientific Corporation
Cardiovascular · 138d
Cleared May 12, 2017
Unity Network ID
K170199 · MWI
Ge Healthcare
Cardiovascular · 109d
Cleared May 11, 2017
Fully Automatic Electronic Blood Pressure Monitor
K163276 · DXN
Andon Health Co, Ltd.
Cardiovascular · 171d
Cleared May 11, 2017
Anybattery C2 Rechargeable Battery
K160667 · DPS
Anybattery, Inc.
Cardiovascular · 428d
Cleared May 09, 2017
Guider Catheter Introducer
K171081 · DYB
Rhythm Xience, Inc. (Rxi)
Cardiovascular · 28d
Cleared May 09, 2017
EpiAccess System
K170831 · DYB
Epiep, Inc.
Cardiovascular · 50d
Cleared May 09, 2017
Digital Blood Pressure Monitor-Automatic Upper Arm Style
K163606 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 139d
Cleared May 05, 2017
Kent Camera
K163070 · MUD
Kent Imaging, Inc.
Cardiovascular · 184d
Cleared May 03, 2017
A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
K163683 · DXN
A&D Company, Ltd.
Cardiovascular · 126d
Cleared May 03, 2017
The IQool System
K162523 · NZE
Braincool AB
Cardiovascular · 236d