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
841–864 of 18,182
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 CT 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