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
2545–2568 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 23, 2018
Advisor HD Grid Mapping Catheter, Sensor Enabled
K172393 · MTD
St. Jude Medical, Inc.
Cardiovascular · 258d
Cleared Apr 23, 2018
Patient Status Engine
K172329 · DRG
Isansys Lifecare, Ltd.
Cardiovascular · 264d
Cleared Apr 19, 2018
Medtronic Model 53401 External Pulse Generator (EPG)
K180873 · DTE
Medtronic, Inc.
Cardiovascular · 16d
Cleared Apr 19, 2018
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K180007 · LIT
Creagh Medical, Ltd.
Cardiovascular · 107d
Cleared Apr 18, 2018
RAILWAY Sheathless Access System
K180081 · DYB
Cordis Corporation
Cardiovascular · 97d
Cleared Apr 18, 2018
Wingman 35 Crossing Catheter
K173661 · DQY
Reflow Medical, Inc.
Cardiovascular · 140d
Cleared Apr 18, 2018
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K172880 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 209d
Cleared Apr 17, 2018
PreludeSYNC DISTAL Radial Compression System
K180723 · DXC
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Apr 17, 2018
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy...
K180416 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 61d
Cleared Apr 16, 2018
CardiMax Electrocardiograph
K173226 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 195d
Cleared Apr 12, 2018
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
K180795 · DQX
Boston Scientific
Cardiovascular · 16d
Cleared Apr 12, 2018
Admiral Xtreme
K173515 · LIT
Medtronic Vascular
Cardiovascular · 149d
Cleared Apr 12, 2018
Straub Endovascular System
K172315 · MCW
Straub Medical AG
Cardiovascular · 254d
Cleared Apr 11, 2018
Inno-Hydrowire
K172187 · DQX
Suzhou Innomed Medical Device Co., Ltd.
Cardiovascular · 265d
Cleared Apr 10, 2018
Digital Automatic Wrist Blood Pressure Monitor MD4300
K171379 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 334d
Cleared Apr 09, 2018
ClotTriever Thrombectomy System
K180329 · QEW
Inari Medical, Inc.
Cardiovascular · 62d
Cleared Apr 05, 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...
K180694 · MCW
Spectranetics, Inc.
Cardiovascular · 20d
Cleared Apr 05, 2018
VAMP Venous/Arterial Blood Management Protection System
K173586 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 136d
Cleared Apr 05, 2018
Wedge Microcatheter
K172014 · DQY
MicroVention, Inc.
Cardiovascular · 276d
Cleared Apr 04, 2018
TrapLiner catheter
K180088 · DQY
Vascular Solutions, Inc.
Cardiovascular · 82d
Cleared Apr 03, 2018
Surefire Spark Infusion System
K180677 · DQO
Surefire Medical, Inc.
Cardiovascular · 19d
Cleared Apr 03, 2018
Unite Connect for Clinical Systems
K180566 · MSX
Ascom (Sweden) AB
Cardiovascular · 29d
Cleared Apr 03, 2018
High-Flo Silver Polyethylene Catheter
K172635 · DQO
Cook Incorporated
Cardiovascular · 214d
Cleared Mar 30, 2018
Merit Pursue Microcatheter
K173548 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 134d