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
121–144 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 23, 2026
Introducer Sheath Set
K254248 · DYB
Cardiocycle Medical(Suzhou) Co., Ltd.
Cardiovascular · 115d
Cleared Apr 23, 2026
Liberant™ RX Aspiration Catheter
K253589 · QEZ
Medtronic Interventional Vascular, Inc.
Cardiovascular · 157d
Cleared Apr 23, 2026
Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
K252389 · DSH
Smwmed, Inc.
Cardiovascular · 266d
Cleared Apr 21, 2026
Korotkoff sound blood pressure monitor
K253982 · DXN
Beijing Hanvon Health Technology Co.,...
Cardiovascular · 130d
Cleared Apr 21, 2026
RhythmStar System (SL)
K250793 · QYX
RhythMedix, LLC
Cardiovascular · 403d
Cleared Apr 20, 2026
EnSite™ X EP System
K260212 · DQK
Abbott Medical
Cardiovascular · 87d
Cleared Apr 17, 2026
Neonav ECG Tip Location System
K260929 · LJS
Navi Medical Technologies
Cardiovascular · 28d
Cleared Apr 17, 2026
Edwards eSheath+ introducer set
K254279 · DYB
Edwards Lifesciences
Cardiovascular · 108d
Cleared Apr 17, 2026
Novasight Hybrid System
K252945 · OBJ
Conavi Medical, Inc.
Cardiovascular · 214d
Not Cleared Apr 17, 2026
XplantR Explant Tool
DEN250033 · SHR
Hjarta Care, LLC
Cardiovascular · 253d
Cleared Apr 16, 2026
Hot Pink Pad Warming System
K260903 · DWJ
Xodus Medical, Inc.
Cardiovascular · 29d
Cleared Apr 16, 2026
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
K253170 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 202d
Cleared Apr 14, 2026
TriMemo™ SEMIRIGID ANNULOPLASTY RING
K260498 · KRH
Corcym S.r.l.
Cardiovascular · 60d
Cleared Apr 13, 2026
Aventus Introducer Sheath
K260091 · DYB
Inquis Medical
Cardiovascular · 91d
Cleared Apr 13, 2026
ACORYS MAPPING SYSTEM
K253861 · DQK
Corify Care S.L
Cardiovascular · 131d
Cleared Apr 10, 2026
Protaryx Transseptal Puncture Device (PTX2-001)
K260839 · DYB
Protaryx Medical, Inc.
Cardiovascular · 28d
Cleared Apr 10, 2026
LOBO Vascular Occlusion System
K260508 · KRD
Okami Medical, Inc.
Cardiovascular · 52d
Cleared Apr 10, 2026
Auryon Atherectomy System
K260244 · MCW
Eximo Medical
Cardiovascular · 73d
Cleared Apr 10, 2026
Teleport Glide Microcatheter
K253361 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 192d
Cleared Apr 10, 2026
Vista 300/Vista 300 S
K252250 · MHX
Shanghai Draeger Medical Instrument...
Cardiovascular · 267d
Cleared Apr 08, 2026
OptiCross Coronary Imaging Catheter (H749518110)
K260816 · OBJ
Boston Scientific
Cardiovascular · 26d
Cleared Apr 07, 2026
AuST Steerable Sheath
K260942 · DYB
CenterPoint Systems, LLC
Cardiovascular · 18d
Cleared Apr 07, 2026
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
K253801 · SHP
Anumana, Inc.
Cardiovascular · 130d
Cleared Apr 07, 2026
Warming System
K252861 · DWJ
Hangzhou Tappa Medical Technology...
Cardiovascular · 210d