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
2137–2160 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 05, 2019
Crossing Support Catheter
K183305 · DQY
Tractus Vascular, LLC
Cardiovascular · 250d
Cleared Aug 02, 2019
Epicardial Access System
K191546 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 51d
Cleared Aug 02, 2019
DynoSense Vital Sign Measuring System
K190090 · MWI
Dynosense Corp.
Cardiovascular · 197d
Cleared Aug 02, 2019
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital...
K181154 · DXN
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 458d
Cleared Aug 01, 2019
Biotronik Stylets
K191469 · DRB
Biotronik, Inc.
Cardiovascular · 59d
Cleared Aug 01, 2019
Steerable Introducer
K191190 · DYB
Freudenberg Medical, LLC
Cardiovascular · 90d
Cleared Aug 01, 2019
MINAMO
K190176 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 181d
Cleared Jul 30, 2019
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
K190132 · DRF
Medtronic
Cardiovascular · 183d
Cleared Jul 30, 2019
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable...
K183547 · DRF
Medtronic
Cardiovascular · 222d
Cleared Jul 29, 2019
Non-invasive blood pressure measurement systems
K190886 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 116d
Cleared Jul 25, 2019
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
K191173 · NTE
Abbott Vascular
Cardiovascular · 85d
Cleared Jul 25, 2019
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of...
K183066 · DYB
Access Scientific, LLC
Cardiovascular · 262d
Cleared Jul 24, 2019
Coolrail Linear Pen
K190587 · OCL
AtriCure, Inc.
Cardiovascular · 139d
Cleared Jul 22, 2019
Digital Automatic Blood Pressure Monitor MD36 Series
K191593 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 38d
Cleared Jul 22, 2019
Plexus SCD110 Sequential Compression Device Sleeve
K190975 · JOW
Midway Medical, LLC
Cardiovascular · 98d
Cleared Jul 22, 2019
Roadrunner PC Wire Guide, Olcott Torque Device
K182985 · DQX
Cook Incorporated
Cardiovascular · 266d
Cleared Jul 20, 2019
CARTO 3 EP Navigation System, Version 7.1 and Accessories
K191660 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Jul 19, 2019
AeroDVx System
K183349 · JOW
Sun Scientific, Inc.
Cardiovascular · 228d
Cleared Jul 16, 2019
Impress Angiographic Catheter
K191608 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Jul 12, 2019
Wearable Device, Wearable Package
K191272 · MSX
Current Health , Ltd.
Cardiovascular · 60d
Cleared Jul 12, 2019
Radial Medical Compression System
K190976 · JOW
Radial Medical, Inc.
Cardiovascular · 88d
Cleared Jul 10, 2019
CentriMag Acute Circulatory Support System
K191557 · DWA
Thoratec Corporation (Now Part of...
Cardiovascular · 28d
Cleared Jul 10, 2019
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K190818 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 100d
Cleared Jul 10, 2019
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K190011 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 188d