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
1729–1752 of 18,110
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 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