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
1777–1800 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 30, 2020
Smart Alarm Interface
K193421 · MSX
Boxview, LLC
Cardiovascular · 326d
Cleared Oct 30, 2020
eCordum Cardiac Monitor (eCordum CM)
K193296 · DXH
Ecordum, Inc.
Cardiovascular · 338d
Cleared Oct 26, 2020
coraForce and coraFlex Support Catheters
K201811 · DQY
Reflow Medical, Inc.
Cardiovascular · 117d
Cleared Oct 23, 2020
Drakon and Sequre Microcatheters
K202797 · DQO
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 30d
Cleared Oct 23, 2020
OXY-1 System
K200109 · DTZ
Abiomed, Inc.
Cardiovascular · 280d
Cleared Oct 16, 2020
Quantum Ventilation Module
K202733 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 28d
Cleared Oct 16, 2020
Selectra 3D Outer Guiding Catheters
K193474 · DQY
Biotronik, Inc.
Cardiovascular · 305d
Cleared Oct 14, 2020
Merit Hydrophilic Guide Wire
K201595 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 124d
Cleared Oct 09, 2020
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
K201377 · LIT
Cordis Corporation
Cardiovascular · 136d
Cleared Oct 09, 2020
Multi-LinkTM X2 ECG Adapter and Leadwires
K200510 · DSA
Vyaire Medical, Inc.
Cardiovascular · 221d
Cleared Oct 09, 2020
V20, V20a, AVSM3 SNF
K200434 · DXN
Mediana Co., Ltd.
Cardiovascular · 228d
Cleared Oct 09, 2020
Stethee Pro 1, Stethee Pro Software System
K193631 · DQD
M3Dicine Pty , Ltd.
Cardiovascular · 287d
Cleared Oct 08, 2020
ECG App
K201525 · QDA
Apple, Inc.
Cardiovascular · 122d
Cleared Oct 06, 2020
iSleeve Introducer Set
K202584 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 06, 2020
TruForm Sievers Annuloplasty Ring
K202253 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 57d
Cleared Oct 02, 2020
Quantum Workstation 12 Elite
K202557 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 29d
Cleared Oct 02, 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · QEW
Boston Scientific Corporation
Cardiovascular · 57d
Cleared Oct 01, 2020
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
K201446 · DQK
Edwards Lifesiences, LLC
Cardiovascular · 122d
Cleared Oct 01, 2020
ECG Cables and Leadwires
K201359 · DSA
Xinkang Medical Instrument Co. , Ltd.
Cardiovascular · 133d
Cleared Sep 29, 2020
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50...
K191738 · DPS
Philips Medical Systems
Cardiovascular · 459d
Cleared Sep 28, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide...
K202543 · DQX
Volcano Corporation
Cardiovascular · 26d
Cleared Sep 23, 2020
Halo AF Detection System
K201208 · DXH
Livmor
Cardiovascular · 141d
Cleared Sep 21, 2020
Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
K201467 · DXN
Bioland Technology, Ltd.
Cardiovascular · 111d
Cleared Sep 21, 2020
Pounce Thrombus Retrieval System
K192814 · QEW
Surmodics,Inc.
Cardiovascular · 356d