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
3505–3528 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 06, 2015
ReDs Wearable System
K150095 · DSB
Sensible Medical Innovations , Ltd.
Cardiovascular · 202d
Cleared Aug 03, 2015
Metacross RX PTA Balloon Dilitation Catheter
K150865 · DQY
KANEKA Corporation
Cardiovascular · 124d
Cleared Aug 03, 2015
Medtronic Confida Brecker Guidewire
K150465 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 161d
Cleared Jul 31, 2015
Zephyr Vascular Compression Device
K151363 · DXC
Advanced Vascular Dynamics
Cardiovascular · 71d
Cleared Jul 31, 2015
B40i Patient Monitor
K143676 · MHX
GE Healthcare Finland Oy
Cardiovascular · 219d
Cleared Jul 31, 2015
NIRO-200NX
K143219 · MUD
Hamamatsu Photonics K.K.
Cardiovascular · 263d
Cleared Jul 29, 2015
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
K150107 · DQY
Micro Therapeutics Inc Dba Ev3...
Cardiovascular · 190d
Cleared Jul 28, 2015
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification
K142829 · DYB
Cook Incorporated
Cardiovascular · 301d
Cleared Jul 24, 2015
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
K150347 · DPW
Deltex Medical Limited
Cardiovascular · 163d
Cleared Jul 24, 2015
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
K143193 · LIT
Boston Scientific
Cardiovascular · 260d
Cleared Jul 24, 2015
Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
K142819 · DYB
Cook Incorporated
Cardiovascular · 298d
Cleared Jul 23, 2015
Magellan Robotic System
K151730 · DXX
Hansen Medical, Inc.
Cardiovascular · 27d
Cleared Jul 23, 2015
Digital Automatic Blood Pressure Monitor MD2300
K143735 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 205d
Cleared Jul 23, 2015
TRANSONIC TISSUE PERFUSION MONITOR
K140740 · DPW
Transonic Systems, Inc.
Cardiovascular · 485d
Cleared Jul 22, 2015
Retracta Detachable Embolization Coil
K151676 · KRD
Cook Incorporated
Cardiovascular · 30d
Cleared Jul 22, 2015
TM-ABI system
K143152 · JOM
Ld Technology, LLC
Cardiovascular · 261d
Cleared Jul 20, 2015
Visi Mobile Monitoring System, Visi Mobile Chest Sensor
K142827 · MHX
Sotera Wireless, Inc.
Cardiovascular · 293d
Cleared Jul 17, 2015
IntelliVue Patient Monitor
K151681 · DSI
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 25d
Cleared Jul 16, 2015
Uncoated Tubing and Connector Components
K151523 · DWF
Medtronic, Inc.
Cardiovascular · 41d
Cleared Jul 16, 2015
ActiveCare+SFT
K151377 · JOW
Medical Compression System (Dbn) , Ltd.
Cardiovascular · 55d
Cleared Jul 16, 2015
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
K150953 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 98d
Cleared Jul 15, 2015
St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology...
K151622 · DRF
St Jude Medical
Cardiovascular · 29d
Cleared Jul 14, 2015
Microlife Wrist Watch Blood Pressure Monitor
K151330 · DXN
Microlife Intellectual Property GmbH,...
Cardiovascular · 56d
Cleared Jul 14, 2015
Rapid Hair Removal Pads
K150349 · LDD
Full Power Aed
Cardiovascular · 153d