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
769–792 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 22, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8...
K240225 · PPN
Shockwave Medical, Inc.
Cardiovascular · 56d
Cleared Mar 22, 2024
Corsano CardioWatch 287-2 System
K232548 · MSX
Corsano Health B.V.
Cardiovascular · 212d
Cleared Mar 22, 2024
Vios Monitoring System(TM) Model 2050
K232354 · DRT
Murata Vios, Inc.
Cardiovascular · 228d
Cleared Mar 20, 2024
Aneroid Sphygmomanometer with Stethoscope
K240165 · DXQ
Wenzhou Longwan Medical Device Factory
Cardiovascular · 58d
Cleared Mar 19, 2024
Blood Pressure Monitor
K233146 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 174d
Cleared Mar 15, 2024
Aventus Thrombectomy System (IM-2001/IM-0002)
K240117 · QEW
Inquis Medical
Cardiovascular · 59d
Cleared Mar 15, 2024
Wrist Blood Pressure Monitor (222)
K233799 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 107d
Cleared Mar 14, 2024
LumiGuide Wire
K233853 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 100d
Cleared Mar 08, 2024
SENDERO Microcatheter
K240384 · DQY
Okami Medical, Inc.
Cardiovascular · 29d
Cleared Mar 08, 2024
Affera Mapping System (AFR-00003)
K233943 · DQK
Medtronic, Inc.
Cardiovascular · 85d
Cleared Mar 08, 2024
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
K233038 · MWI
Edan Instruments, Inc.
Cardiovascular · 165d
Cleared Mar 07, 2024
D·Kutting™ PTA Scoring Balloon Dilatation Catheter
K232207 · PNO
Dk Medical Technology Co., Ltd.
Cardiovascular · 225d
Cleared Mar 06, 2024
DVT Motion Pneumatic Compression Device
K232270 · JOW
Koge Micro Tech Co., Ltd.
Cardiovascular · 219d
Cleared Mar 01, 2024
GORE® PROPATEN® Vascular Graft
K240083 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 50d
Cleared Feb 29, 2024
Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
K240257 · DTK
Bd
Cardiovascular · 29d
Cleared Feb 28, 2024
PowerWire Radiofrequency Guidewire Kit
K232562 · PDU
Baylis Medical Technologies, Inc.
Cardiovascular · 188d
Cleared Feb 23, 2024
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
K240190 · DTR
Medtronic
Cardiovascular · 30d
Cleared Feb 23, 2024
Lymphedema Compression
K240011 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 52d
Cleared Feb 23, 2024
Soldier Microcatheter
K232536 · DQO
Embolx, Inc.
Cardiovascular · 186d
Cleared Feb 22, 2024
R501 - R502 aortic root cannulae with and without vent line (R501-15:...
K240193 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Feb 21, 2024
Cocoon Convective Warming System, Model CWS7000
K232502 · DWJ
Care Essentials Pty, Ltd.
Cardiovascular · 187d
Not Cleared Feb 21, 2024
BraidE Embolization Assist Device
DEN230064 · QZU
Rapid Medical , Ltd.
Cardiovascular · 155d
Cleared Feb 16, 2024
VasQ
K240119 · QVQ
Laminate Medical Technologies , Ltd.
Cardiovascular · 31d
Cleared Feb 16, 2024
S-Patch (S-Patch ExL)
K233906 · DSH
Wellysis Corp.
Cardiovascular · 66d