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
265–288 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 25, 2025
Akura Thrombectomy System
K251070 · QEW
Akura Medical
Cardiovascular · 232d
Cleared Nov 25, 2025
FEops HEARTguide Simulation Application
K250635 · QQI
Feops NV
Cardiovascular · 267d
Cleared Nov 24, 2025
NeVa PV Thrombectomy Device
K253407 · QEX
Vesalio, Inc.
Cardiovascular · 55d
Cleared Nov 24, 2025
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · QEZ
AngioDynamics, Inc.
Cardiovascular · 108d
Cleared Nov 24, 2025
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
K242503 · DTZ
Eurosets S.R.L
Cardiovascular · 459d
Cleared Nov 21, 2025
CardioVision
K251293 · QUO
Icardio.Ai
Cardiovascular · 210d
Cleared Nov 20, 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND)
K253070 · DXC
Medline Industries, LP
Cardiovascular · 58d
Cleared Nov 20, 2025
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K251904 · DPW
Remington Medical, Inc.
Cardiovascular · 153d
Cleared Nov 18, 2025
Hexoskin Medical System (7100-00016)
K243981 · DXH
Carre Technologies, Inc.
Cardiovascular · 330d
Cleared Nov 17, 2025
PM2™ System with ECGuide™ Connector
K252792 · LJS
Piccolo Medical, Inc.
Cardiovascular · 76d
Cleared Nov 13, 2025
TELLTALE Electrosurgical Guidewire System
K252592 · SGO
Telltale, LLC
Cardiovascular · 90d
Cleared Nov 10, 2025
Withings BeamO (SCT02)
K252474 · DPS
Withings
Cardiovascular · 96d
Cleared Nov 10, 2025
IntelliVue Patient Monitor MX750
K251702 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 161d
Cleared Nov 09, 2025
Lunderquist Extra Stiff Wire Guide
K251596 · DQX
William Cook Europe Aps
Cardiovascular · 166d
Cleared Nov 06, 2025
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
K251792 · DXX
Stereotaxis, Inc.
Cardiovascular · 148d
Cleared Oct 30, 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
K253376 · KRD
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Oct 30, 2025
Arctx Cool Catheter Set
K250632 · PLA
Arctx Medical
Cardiovascular · 241d
Cleared Oct 29, 2025
Protrieve Sheath
K253323 · QEW
Inari Medical
Cardiovascular · 29d
Cleared Oct 29, 2025
Seguin Annuloplasty Ring
K253232 · KRH
Abbott Medical
Cardiovascular · 30d
Cleared Oct 29, 2025
Telescope Guide Extension Catheter
K252390 · DQY
Medtronic, Ireland
Cardiovascular · 90d
Cleared Oct 29, 2025
SANSA HSAT
K250882 · MNR
Huxley Medical
Cardiovascular · 219d
Cleared Oct 28, 2025
Visions® PV .014P RX Digital IVUS Catheter
K253399 · OBJ
Volcano Corporation (Dba Philips...
Cardiovascular · 28d
Cleared Oct 28, 2025
VenAir, Sequential Compression System (9P-089000)
K251466 · JOW
Wellell, Inc.
Cardiovascular · 168d
Cleared Oct 27, 2025
Blood Pressure Monitor (B73, BE23T)
K251331 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 180d