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
481–504 of 18,110
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 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