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
1657–1680 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 07, 2021
Arterial Catheter
K201726 · DQY
Haolang Medical USA Corporation
Cardiovascular · 379d
Cleared Jul 06, 2021
SafeCross Transseptal Puncture and Introducer (TSP/I) System
K203459 · DYB
East End Medical I, LLC
Cardiovascular · 224d
Cleared Jul 02, 2021
Selethru(TM) NC PTCA Balloon Dilatation Catheter
K211393 · LOX
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 58d
Cleared Jun 30, 2021
KardiaMobile 6L
K210753 · DXH
AliveCor, Inc.
Cardiovascular · 107d
Cleared Jun 30, 2021
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50...
K210560 · DPS
Philips Medical Systems
Cardiovascular · 125d
Cleared Jun 30, 2021
Quantum Perfusion Arterial Cannula Graft
K203057 · DWF
Qura S.R.L
Cardiovascular · 265d
Cleared Jun 25, 2021
iLab Polaris Multi-Modality Guidance System
K210889 · DQK
Boston Scientific Corporation
Cardiovascular · 92d
Cleared Jun 23, 2021
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K201806 · MTD
Sterilmed Inc. (Johnson and Johnson)
Cardiovascular · 357d
Cleared Jun 16, 2021
Sublime Radial Access 018 RX Dilatation Catheter
K211044 · LIT
Creagh Medical Ltd. (A Wholly Owned...
Cardiovascular · 69d
Cleared Jun 14, 2021
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix...
K211518 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 28d
Cleared Jun 11, 2021
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
K210484 · MXD
Medtronic, Inc.
Cardiovascular · 112d
Cleared Jun 10, 2021
BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular...
K211061 · QEY
Thrombolex, Inc.
Cardiovascular · 62d
Cleared Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458 · NQQ
Abbott Medical
Cardiovascular · 112d
Cleared Jun 07, 2021
HRVWatch-Mini Wrist Monitor
K201914 · DXN
Taiwan Scientific Corporation
Cardiovascular · 333d
Cleared Jun 04, 2021
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · QEZ
AngioDynamics, Inc.
Cardiovascular · 53d
Cleared Jun 03, 2021
Breezeway II
K210627 · DYB
Oscor, Inc.
Cardiovascular · 93d
Cleared Jun 03, 2021
PCA-C1 series Patient Cable
K200722 · DSA
QT Medical, Inc.
Cardiovascular · 441d
Cleared May 28, 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311 · OCL
AtriCure, Inc.
Cardiovascular · 28d
Cleared May 28, 2021
LINQ II Insertable Cardiac Monitor
K211304 · MXD
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 28, 2021
coraCross
K210188 · DQY
Reflow Medical
Cardiovascular · 123d
Cleared May 28, 2021
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension...
K203687 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 162d
Cleared May 27, 2021
BIB Stent Placement Catheter
K211134 · NVM
NuMED, Inc.
Cardiovascular · 41d
Cleared May 26, 2021
PlasmaWave
K211253 · JOW
Manamed, Inc.
Cardiovascular · 30d
Cleared May 26, 2021
ViperCath XC Peripheral Exchange Catheter
K211251 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 30d