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
2809–2832 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 27, 2017
Fully Automatic Blood Pressure Monitor
K171282 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jul 27, 2017
Bunegin-Albin Air Aspiration Set
K163031 · DXE
Cook Incorporated
Cardiovascular · 269d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · DQY
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 25, 2017
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
K170997 · DYB
Biosense Webster, Inc.
Cardiovascular · 113d
Cleared Jul 25, 2017
CARTO 3 EP Navigation System, Version 6.0 and Accessories
K170600 · DQK
Biosense Webster, Inc.
Cardiovascular · 146d
Cleared Jul 21, 2017
True Form Reshapable Guide Wire
K170532 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 149d
Cleared Jul 21, 2017
Progreat
K170223 · DQO
Ashitaka Factory of Terumo Corporation
Cardiovascular · 177d
Cleared Jul 19, 2017
Vela RX PTA Balloon Dilatation Catheter
K171290 · LIT
Curatia Medical
Cardiovascular · 78d
Cleared Jul 19, 2017
Mini Stick ENVI Non-Vascular Introducer Kit
K170775 · DYB
AngioDynamics, Inc.
Cardiovascular · 127d
Cleared Jul 19, 2017
CARDIOVIT FT-1
K170182 · DPS
Schiller AG
Cardiovascular · 177d
Cleared Jul 18, 2017
Altrix Temperature Management Wraps
K171149 · DWJ
Stryker Medical
Cardiovascular · 90d
Cleared Jul 14, 2017
eCareCoordinator
K171029 · DRG
Visicu, Inc.
Cardiovascular · 99d
Cleared Jul 14, 2017
Dictum Health
K170798 · MWI
Dictum Health, Inc.
Cardiovascular · 119d
Cleared Jul 14, 2017
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K162803 · DSY
Vascutek, Ltd.
Cardiovascular · 282d
Cleared Jul 12, 2017
Reprocessed AcuNav Diagnostic Ultrasound Catheter
K163560 · OWQ
Innovative Health, LLC
Cardiovascular · 205d
Cleared Jul 11, 2017
Devon 24
K170814 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 116d
Cleared Jul 11, 2017
Needle's Eye Snare Retrieval Set - 54cm
K163353 · DXE
Cook Incorporated
Cardiovascular · 223d
Cleared Jul 07, 2017
Smart Syringe
K171698 · DXT
Osprey Medical, Inc.
Cardiovascular · 29d
Cleared Jul 07, 2017
RX NC Takeru PTCA Balloon Dilatation Catheter
K170941 · LOX
KANEKA Corporation
Cardiovascular · 99d
Cleared Jul 07, 2017
Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic...
K163648 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 196d
Cleared Jul 07, 2017
M3290B Philips IntelliVue Information Center iX
K163584 · MHX
Philips Medical Systems
Cardiovascular · 199d
Cleared Jul 06, 2017
PSA Cable
K170815 · DTC
Boston Scientific Corporation
Cardiovascular · 111d
Cleared Jul 06, 2017
Tempus Pro Patient Monitor
K170567 · MHX
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 129d
Cleared Jul 03, 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 28d