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
193–216 of 18,182
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