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
553–576 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 20, 2025
iSLEEVE Introducer Set
K250468 · DYB
Boston Scientific
Cardiovascular · 30d
Cleared Mar 20, 2025
ViaOne Epicardial Access System
K243928 · DYB
Cardiovia , Ltd.
Cardiovascular · 90d
Cleared Mar 20, 2025
Starlight Imaging Catheter
K243016 · NQQ
Spectrawave, Inc.
Cardiovascular · 174d
Cleared Mar 18, 2025
CarbonCool® System
K240933 · NZE
Global Healthcare SG Sdn. Bhd
Cardiovascular · 347d
Cleared Mar 16, 2025
Catapult Guide Sheath
K250439 · DYB
Contract Medical International, GmbH
Cardiovascular · 30d
Cleared Mar 14, 2025
KOROT Blood Pressure Monitor (KOROT P3 Accurate)
K250091 · DXN
Korot Co., Ltd.
Cardiovascular · 59d
Cleared Mar 14, 2025
Ruby XL System
K250079 · KRD
Penumbra, Inc.
Cardiovascular · 60d
Cleared Mar 13, 2025
Turbo-Elite Laser Atherectomy Catheter
K250385 · MCW
Spectranetics
Cardiovascular · 30d
Cleared CT Mar 13, 2025
FlowTriever2 Catheter
K250088 · QEW
Inari Medical, Inc.
Cardiovascular · 58d
Cleared Mar 11, 2025
OutFlo Aortic Valve Dilatation Balloon Catheter
K241562 · OZT
Disa Medinotec
Cardiovascular · 284d
Cleared Mar 10, 2025
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter...
K243101 · OWQ
Surgical Instrument Service and...
Cardiovascular · 161d
Cleared Mar 06, 2025
Intra-Operative Positioning System (IOPS®)
K243842 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 83d
Cleared Mar 05, 2025
CROSSLEAD 0.018inch
K242597 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 187d
Cleared Feb 28, 2025
Seclusion Catheter
K243436 · DQY
Basis Medical
Cardiovascular · 115d
Cleared Feb 27, 2025
Parafleet SC 014 PTA Balloon Dilatation Catheter
K243704 · LIT
Brosmed Medical Co., Ltd.
Cardiovascular · 90d
Cleared Feb 27, 2025
Gelweave™ Vascular Prostheses
K241550 · DSY
Vascutek, Ltd.
Cardiovascular · 272d
Cleared Feb 26, 2025
Aventus Thrombectomy System
K250202 · QEW
Inquis Medical
Cardiovascular · 33d
Cleared Feb 26, 2025
pilot TLS
K241587 · LJS
Vygon Corporation
Cardiovascular · 268d
Cleared Feb 26, 2025
Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i)
K241576 · OGZ
Infraredx, Inc.
Cardiovascular · 268d
Cleared Feb 25, 2025
Loss of Pulse Detection
K242967 · SDY
Fitbit
Cardiovascular · 152d
Cleared Feb 21, 2025
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including...
K243115 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 144d
Cleared Feb 20, 2025
CER-S
K243312 · DQK
Cardiocalm Srl
Cardiovascular · 121d
Cleared Feb 19, 2025
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323,...
K241578 · DXN
Shenzhen Bsx Technology Electronics...
Cardiovascular · 261d
Cleared Feb 14, 2025
LimFlow V-Ceiver
K242776 · MMX
LimFlow, Inc.
Cardiovascular · 154d