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
2617–2640 of 18,182
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