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
3337–3360 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 14, 2016
Cronus HP - High Pressure Peripheral Balloon Catheter
K151141 · LIT
Nipro Medical Corporation
Cardiovascular · 260d
Cleared Jan 13, 2016
IntraNovo Microcatheter
K153125 · DQO
Texasmedical Technologies, Inc.
Cardiovascular · 76d
Cleared Jan 13, 2016
FFRct
K152733 · PJA
HeartFlow, Inc.
Cardiovascular · 113d
Cleared Jan 12, 2016
MUSE Cardiology Information System
K152993 · DQK
Ge Medical Systems Information...
Cardiovascular · 91d
Cleared Jan 11, 2016
Fortress Introducer Sheath SYstem
K153197 · DYB
Contract Medical International, GmbH
Cardiovascular · 68d
Cleared Jan 08, 2016
LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
K152876 · DQY
Tni Manufacturing, Inc.
Cardiovascular · 100d
Cleared Jan 07, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K153214 · DXN
Health & Life Co., Ltd.
Cardiovascular · 63d
Cleared Jan 07, 2016
Edwards Balloon Catheter
K153069 · OMZ
Edwards Lifesciences
Cardiovascular · 77d
Cleared Jan 07, 2016
Sterile High-pressure Angiographic Syringes for Single-use
K151960 · DXT
Shenzhen Baoan Medical Supplies Co.,...
Cardiovascular · 175d
Cleared Jan 06, 2016
ClariVein IC
K153502 · KRA
Vascular Insights, LLC
Cardiovascular · 30d
Cleared Jan 06, 2016
VasoStat Hemostasis Device
K153259 · DXC
Forge Medical, Inc.
Cardiovascular · 57d
Cleared Jan 06, 2016
Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing...
K152944 · DPS
Mortara Instrument, Inc.
Cardiovascular · 92d
Cleared Jan 05, 2016
SoloPath Re-Collapsible Access System
K152498 · DYB
Onset Medical Corporation
Cardiovascular · 126d
Cleared Dec 31, 2015
Visions PV .035 Digital IVUS Catheter
K153094 · OBJ
Volcano Corporation
Cardiovascular · 66d
Cleared Dec 23, 2015
Expression MR400 MRI Patient Monitoring System
K152330 · MWI
Invivo Corporation
Cardiovascular · 127d
Cleared Dec 21, 2015
Defibrillator Analyzer Variable Load
K153210 · DRL
Bc Group International, Inc.
Cardiovascular · 46d
Cleared Dec 21, 2015
Cerner CareAware Event Management
K151672 · MSX
Cerner Corporation
Cardiovascular · 182d
Cleared Dec 21, 2015
HydroPearl Microspheres, HydroPearl Microspheres
K150870 · KRD
MicroVention, Inc.
Cardiovascular · 264d
Cleared Dec 18, 2015
Fluent Inflation Device
K152387 · MAV
Vascular Solutions, Inc.
Cardiovascular · 116d
Cleared Dec 18, 2015
Digital Electrocardiograph
K152384 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 116d
Cleared Dec 18, 2015
V8 Balloon Aortic Valvuloplasty Catheter
K152150 · OZT
Intervalve, Inc.
Cardiovascular · 137d
Cleared Dec 18, 2015
Foresight Intracardiac Echocardiography (ICE) System
K151126 · DQO
Colibri Technologies, Inc.
Cardiovascular · 234d
Cleared Dec 18, 2015
MReye Flipper Detachable Embolization Coil and Delivery System
K150964 · KRD
Cook Incorporated
Cardiovascular · 252d
Cleared Dec 18, 2015
MReye Embolization Coils
K150931 · KRD
Cook Incorporated
Cardiovascular · 256d