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
337–360 of 18,182
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 CT 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 CT Nov 13, 2025
TELLTALE Electrosurgical Guidewire System
K252592 · SGO
Telltale, LLC
Cardiovascular · 90d
Cleared CT 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 CT 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