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
2401–2424 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 20, 2018
Dilator Sets
K183036 · DRE
Cook Incorporated
Cardiovascular · 49d
Cleared Dec 20, 2018
Phoenix Atherectomy System
K182972 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 55d
Cleared Dec 20, 2018
ASAHI Corsair Pro XS
K182420 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 106d
Cleared Dec 20, 2018
Reuter Tip Deflecting Wire Guide
K180830 · DQX
Cook Incorporated
Cardiovascular · 265d
Cleared Dec 19, 2018
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation...
K182610 · OCL
Medtronic
Cardiovascular · 89d
Cleared CT Dec 19, 2018
FFRangio System
K182149 · QEK
Cathworks, Ltd.
Cardiovascular · 133d
Cleared Dec 19, 2018
Arterial Pressure Monitoring Set/Tray
K180846 · DQO
Cook Incorporated
Cardiovascular · 261d
Cleared Dec 18, 2018
Devon 52 Sequential Compression Device
K182150 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 132d
Cleared Dec 17, 2018
Reusable Silicone Cover CPRmeter 2
K183348 · LIX
Laerdal Medical AS
Cardiovascular · 14d
Cleared Dec 17, 2018
FlowTriever Retrieval/Aspiration System
K183198 · QEW
Inari Medical
Cardiovascular · 28d
Cleared Dec 17, 2018
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433 · DXQ
Shenzhen Caremed Medical Technology...
Cardiovascular · 102d
Cleared Dec 17, 2018
Phoenix 2.4mm Atherectomy Plus System
K181877 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 157d
Cleared Dec 17, 2018
Tyto Stethoscope (OTC)
K181612 · DQD
Tyto Care , Ltd.
Cardiovascular · 181d
Cleared Dec 17, 2018
Handheld VitalSigns Monitoring System
K172965 · MWI
Visiomed Technology Co.,Ltd
Cardiovascular · 447d
Cleared Dec 14, 2018
UniPulse
K182905 · DRL
Seaward Group
Cardiovascular · 59d
Cleared Dec 14, 2018
3880 MRI Patient Monitoring System
K182900 · MWI
Iradimed Corporation
Cardiovascular · 59d
Cleared Dec 14, 2018
Cardio-TriTest v6.5
K182790 · DPS
Cardio-Phoenix, Inc.
Cardiovascular · 74d
Cleared Dec 14, 2018
Xcess Guiding Catheter
K180797 · DQY
Curatia Medical Co.
Cardiovascular · 262d
Cleared Dec 13, 2018
Selectra Catheters, Selectra Accessory Kit
K183265 · DQY
Biotronik, Inc.
Cardiovascular · 20d
Cleared Dec 13, 2018
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
K182397 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 100d
Cleared Dec 13, 2018
DuraSheath Introducer Sheath System
K181463 · DYB
Contract Medical International, GmbH
Cardiovascular · 192d
Cleared Dec 13, 2018
Argos
K181372 · DXG
Retia Medical, LLC
Cardiovascular · 204d
Cleared Dec 12, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
K183128 · DQK
Abbott
Cardiovascular · 29d
Cleared Dec 10, 2018
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision...
K182075 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 131d