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
3217–3240 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 19, 2016
Nanostim Introducer Kit
K161102 · DYB
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared May 19, 2016
Nester Embolization Coils, Tornado Embolization Coils
K153778 · KRD
Cook Incorporated
Cardiovascular · 140d
Cleared May 12, 2016
GORE DrySeal Flex Introducer Sheath
K160254 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 101d
Cleared May 12, 2016
Guiding Catheter
K153703 · DQY
Texasmedical Technologies, Inc.
Cardiovascular · 141d
Cleared May 12, 2016
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution...
K152749 · DPT
Moor Instruments, Ltd.
Cardiovascular · 232d
Cleared May 12, 2016
Venous Assist System
K150980 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 394d
Cleared May 10, 2016
Reprocessed Polaris X Steerable Diagnostic EP Catheter
K160303 · NLH
Innovative Health, LLC
Cardiovascular · 96d
Cleared May 10, 2016
Reprocessed Livewire Steerable Diagnostic EP Catheter
K160242 · NLH
Innovative Health, LLC
Cardiovascular · 99d
Cleared May 06, 2016
Achieve ST Mapping Catheter, Catheter Connecting Cable
K153139 · DRF
Medtronic, Inc.
Cardiovascular · 189d
Cleared May 06, 2016
Digital Blood Pressure Monitor
K152415 · DXN
Suzhou Sunspirit Co., Ltd.
Cardiovascular · 254d
Cleared May 06, 2016
Diagnostic Station DS20
K152043 · DPS
Schiller AG
Cardiovascular · 288d
Cleared May 05, 2016
Philips Efficia CMS200 Central Monitoring System
K160951 · MHX
Philips Medical Systems
Cardiovascular · 30d
Cleared May 05, 2016
PeriFlux6000
K152930 · DPW
Perimed AB
Cardiovascular · 213d
Cleared May 05, 2016
Cogent Hemodynamic Monitoring System
K152006 · DXQ
Icu Medical, Inc.
Cardiovascular · 289d
Cleared May 03, 2016
Swan Ganz Catheters
K160084 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 109d
Cleared Apr 29, 2016
Denali Filter System - Femoral Delivery Kit, Denali Filter System -...
K160866 · DTK
C.R. Bard, Inc.
Cardiovascular · 30d
Cleared Apr 29, 2016
Crosperio OTW
K160013 · LIT
KANEKA Corporation
Cardiovascular · 116d
Cleared Apr 29, 2016
Crosstella OTW
K160004 · LIT
KANEKA Corporation
Cardiovascular · 116d
Cleared Apr 29, 2016
Dyna-Vision Telemonitoring System
K152973 · MHX
Techmedic Development International B.V.
Cardiovascular · 204d
Cleared Apr 29, 2016
Patient Monitor
K152552 · MHX
Edan Instruments, Inc.
Cardiovascular · 234d
Cleared Apr 25, 2016
MMS PTA Balloon Catheter
K152934 · LIT
Micro Medical Solutions, Inc.
Cardiovascular · 203d
Cleared Apr 22, 2016
Reveal LINQ
K160689 · MXD
Medtronic, Inc.
Cardiovascular · 42d
Cleared Apr 22, 2016
U80 Series Upper Arm Electronic Blood Pressure Monitor
K160019 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 108d
Cleared Apr 22, 2016
Matrix Mini ECG Monitor
K152701 · DSI
Global Instrumentation, LLC
Cardiovascular · 214d