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
1609–1632 of 18,110
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