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
1801–1824 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 17, 2020
Wrist Type Blood Pressure Monitor
K200346 · DXN
Avita Corporation
Cardiovascular · 310d
Cleared Dec 15, 2020
Lim Precision Steerable TS, Steerable Sheath, Dilator
K202226 · DYB
Keystone Heart, Ltd.
Cardiovascular · 130d
Cleared Dec 14, 2020
Ventrax Delivery System
K202610 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 96d
Cleared Dec 11, 2020
Drakon and Sequre Microcatheters
K203487 · DQO
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 14d
Cleared Dec 11, 2020
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
K202471 · DSY
Peca Labs
Cardiovascular · 105d
Cleared Dec 11, 2020
CorPath GRX System
K202275 · DXX
Corindus, Inc.
Cardiovascular · 122d
Cleared Dec 11, 2020
Automated ankle brachial pressure index measuring device, MESI mTABLET system
K201046 · JOM
Mesi D.O.O.; Mesi, Development of...
Cardiovascular · 234d
Cleared Dec 10, 2020
Triever20 Curve Catheter
K203333 · QEW
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Dec 10, 2020
JADE
K202231 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 125d
Cleared Dec 08, 2020
Graffiti
K202189 · DQK
Ge Medical Systems Information...
Cardiovascular · 126d
Cleared Dec 08, 2020
Biomonitor III, Biomonitor IIIm
K201865 · MXD
Biotronik, Inc.
Cardiovascular · 155d
Cleared Dec 07, 2020
Impella XR Sheath Set
K202330 · DYB
Abiomed, Inc.
Cardiovascular · 112d
Cleared Dec 07, 2020
B-Secur HeartKey Software Library
K200884 · DPS
B-Secur , Ltd.
Cardiovascular · 249d
Cleared Dec 06, 2020
Transtek Wrist Blood Pressure Monitor
K202599 · DXN
Guangdong Transtek Medical...
Cardiovascular · 89d
Cleared Dec 05, 2020
DVT-2600
K203016 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 65d
Cleared Dec 04, 2020
FlowTriever Retrieval/Aspiration System
K201541 · QEW
Inari Medical
Cardiovascular · 178d
Cleared Dec 04, 2020
Electronic Blood Pressure Monitor
K200716 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 261d
Cleared Dec 04, 2020
InBody
K200442 · DXN
Inbody Co., Ltd.
Cardiovascular · 284d
Cleared CT Dec 02, 2020
Auryon Atherectomy System
K202835 · MCW
Eximo Medical, Ltd.
Cardiovascular · 68d
Cleared Dec 01, 2020
Confirm Rx Insertable Cardiac Monitor
K202876 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 64d
Cleared Dec 01, 2020
AcQMap High Resolution Imaging and Mapping System
K201015 · DQK
Acutus Medical, Inc.
Cardiovascular · 228d
Cleared Nov 25, 2020
T3 Platform software
K202306 · MWI
Etiometry, Inc.
Cardiovascular · 103d
Cleared Nov 25, 2020
EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled,...
K202066 · DQK
Abbott Medical
Cardiovascular · 121d
Cleared Nov 25, 2020
CARTO® 3 EP Navigation System with Signal Processing Unit
K200484 · DQK
Biosense Webster, Inc.
Cardiovascular · 272d