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
1681–1704 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 25, 2021
LUX-Dx Insertable Cardiac Monitor
K210608 · MXD
Boston Scientific Corporation
Cardiovascular · 85d
Cleared May 25, 2021
HeRO Graft, HeRO Adapter
K203724 · DSY
Merit Medical Systems, Inc.
Cardiovascular · 155d
Cleared May 21, 2021
Neurescue device
K210358 · MJN
Neurescue Aps
Cardiovascular · 102d
Cleared May 21, 2021
Zio ECG Utilization Software (ZEUS) System
K202527 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared May 21, 2021
Zio Monitor
K202359 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 275d
Cleared May 20, 2021
Vitals360 Multi-Vitals Mobile Monitor
K210086 · MWI
Vocare, Inc.
Cardiovascular · 127d
Cleared May 14, 2021
AcQGuide MAX Steerable Sheath
K211100 · DRA
Acutus Medical, Inc.
Cardiovascular · 31d
Cleared May 14, 2021
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL,...
K210417 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 92d
Cleared May 14, 2021
Cardiac Trigger Monitor
K202138 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 287d
Cleared May 12, 2021
ClotTriever Thrombectomy System
K210689 · QEW
Inari Medical, Inc.
Cardiovascular · 65d
Cleared May 12, 2021
Automatic Arm Electronic Blood Pressure Monitor
K210435 · DXN
Shenzhen Lepu Intelligent Medical...
Cardiovascular · 89d
Cleared May 07, 2021
Reprocessed Tri Pulse Compression Garment
K203847 · JOW
Renu Medical, Inc.
Cardiovascular · 127d
Cleared May 06, 2021
KardiFlex NC Coronary Dilatation Catheter
K202578 · LOX
Medcaptain Life Science Co., Ltd.
Cardiovascular · 240d
Cleared May 04, 2021
Quantum Mini Ventilation Module
K210669 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 60d
Cleared May 04, 2021
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K203655 · NLH
Innovative Health, LLC
Cardiovascular · 140d
Cleared May 04, 2021
VASSALLO GT Hybrid
K203529 · DQX
Filmecc Co., Ltd.
Cardiovascular · 153d
Cleared May 03, 2021
MC3 Crescent Jugular Dual Lumen Catheter
K203409 · PZS
Mc3, Inc.
Cardiovascular · 165d
Cleared Apr 30, 2021
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16,...
K211013 · QEW
Inari Medical, Inc.
Cardiovascular · 25d
Cleared Apr 30, 2021
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT...
K210647 · DQY
Vascular Solutions, LLC
Cardiovascular · 58d
Cleared Apr 30, 2021
MAC 7 - Resting ECG Analysis System
K203786 · DPS
Ge Medical Systems Information...
Cardiovascular · 123d
Cleared Apr 29, 2021
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
K210605 · DWJ
3M Company
Cardiovascular · 59d
Cleared Apr 29, 2021
KardiFlex PTCA Balloon Dilatation Catheter
K202619 · LOX
Medcaptain Life Science Co., Ltd.
Cardiovascular · 231d
Cleared Apr 28, 2021
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer,...
K202757 · DXN
Contec Medical Systems Co.,Ltd
Cardiovascular · 219d
Cleared Apr 26, 2021
Vital Sign Monitoring Sensor (Model :XK300)
K202464 · DRT
Xandar Kardian, Inc.
Cardiovascular · 242d