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
2329–2352 of 18,110
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 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