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
2929–2952 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 31, 2017
AC3 Series IABP System
K162820 · DSP
Arrow International, Inc.
Cardiovascular · 175d
Cleared Mar 31, 2017
Bluetooth blood pressure monitor
K161530 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 302d
Cleared Mar 30, 2017
Chameleon PTA Balloon Catheter
K170635 · LIT
Av Medical Technologies, Ltd.
Cardiovascular · 28d
Cleared Mar 30, 2017
Esophageal Cooling Device
K170009 · PLA
Advanced Cooling Therapy, LLC
Cardiovascular · 86d
Cleared Mar 28, 2017
Foresight Intracardiac Echocardiology (ICE) System
K162789 · DQO
Conavi Medical, Inc.
Cardiovascular · 175d
Cleared Mar 24, 2017
FFR Link, FFR Signal Processing Module
K170204 · DRG
Boston Scientific Corporation
Cardiovascular · 60d
Cleared Mar 24, 2017
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
K162503 · DSH
Cardiac Insight, Inc.
Cardiovascular · 198d
Cleared Mar 24, 2017
CardioDay V2.5
K162023 · DQK
Getemed Medizin- Und...
Cardiovascular · 245d
Cleared Mar 23, 2017
Guidezilla II Guide Extension Catheter
K163314 · DQY
Boston Scientific Corporation
Cardiovascular · 120d
Cleared Mar 22, 2017
Fathom-16 Steerable Guidewires
K170636 · DQX
Boston Scientific Corporation
Cardiovascular · 20d
Cleared Mar 21, 2017
HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty...
K163608 · PST
Biostable Science & Engineering, Inc.
Cardiovascular · 90d
Cleared Mar 17, 2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K170583 · DTN
Medtronic, Inc.
Cardiovascular · 17d
Cleared Mar 17, 2017
OPT-SHIELD AIR, SUPINE
K162562 · DWJ
Bcg Medical, LLC
Cardiovascular · 184d
Cleared Mar 17, 2017
Consult Station TS
K153600 · DXN
H4D Sas
Cardiovascular · 457d
Cleared Mar 14, 2017
NIVR58-T kit
K161880 · DXJ
Barco N.V.
Cardiovascular · 249d
Cleared Mar 10, 2017
Mikro-Cath Pressure Catheter
K163376 · DXO
Millar, Inc.
Cardiovascular · 99d
Cleared Mar 10, 2017
RHYTHMIA HDx Mapping System
K162793 · DQK
Boston Scientific Corporation
Cardiovascular · 157d
Cleared Mar 10, 2017
Adscope 658 Electronic Stethoscope
K162589 · DQD
American Diagnostic Corp.
Cardiovascular · 175d
Cleared Mar 09, 2017
PhotoFix Decellularized Bovine Pericardium
K162506 · DXZ
Cryolife, Inc.
Cardiovascular · 182d
Cleared Mar 08, 2017
Expro Elite Snare, Sympro Elite Snare
K163307 · MMX
Vascular Solutions, Inc.
Cardiovascular · 105d
Cleared Mar 08, 2017
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
K163054 · DXT
Osprey Medical, Inc.
Cardiovascular · 127d
Cleared Mar 08, 2017
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
K161733 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 258d
Cleared Mar 07, 2017
CenterCross Ultra LV Catheter
K170403 · DQY
Roxwood Medical, Inc.
Cardiovascular · 26d
Cleared Mar 07, 2017
Vado Steerable Sheath
K160721 · DYB
Kalila Medical, Inc.
Cardiovascular · 356d