Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
2209–2232 of 18,182
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