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
385–408 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 09, 2025
Monitor B105M
K242562 · MHX
Ge Medical Systems Information...
Cardiovascular · 315d
Cleared Jul 08, 2025
Quantum Micro-Cardioplegia Delivery System
K240908 · DTR
Spectrum Medical , Ltd.
Cardiovascular · 462d
Cleared Jul 03, 2025
Boomerang Valvulotome (BMGVT080)
K250105 · MGZ
Aveera Medical, Inc.
Cardiovascular · 169d
Cleared Jul 02, 2025
OPUSWAVE Dual Sensor Imaging System
K250684 · NQQ
Terumo Cardiovascular Systems Thi Plant
Cardiovascular · 118d
Cleared Jul 02, 2025
G0 Blood Pressure Monitoring System (G0)
K250415 · DXN
Aktiia SA
Cardiovascular · 139d
Cleared Jun 30, 2025
Otsuka Digital Feedback Device
K251088 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 82d
Cleared Jun 29, 2025
Primum Hydrophilic Guiding Catheter
K250972 · DQY
Pendracare
Cardiovascular · 90d
Cleared Jun 27, 2025
CPS Locator 3D Plus Delivery Catheter
K250828 · DQY
CenterPoint Systems, LLC
Cardiovascular · 100d
Cleared Jun 27, 2025
Easyflow (103-200
K250610 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 119d
Cleared Jun 27, 2025
VIKING™ Fixed Curve Diagnostic Catheter
K250310 · DRF
Boston Scientific Corporation
Cardiovascular · 144d
Cleared Jun 26, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
K250548 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 121d
Cleared Jun 25, 2025
Globe® Pulsed Field System
K250747 · DQK
Kardium, Inc.
Cardiovascular · 105d
Cleared Jun 25, 2025
SAT CenterFlow Molding Balloon Catheter (IN20-00313)
K243184 · DQY
Strait Access Technologies Holdings
Cardiovascular · 268d
Cleared Jun 24, 2025
Bridge Plus Occlusion Balloon (590-002)
K251358 · MJN
Philips Image Guided Therapy Devices
Cardiovascular · 55d
Cleared Jun 24, 2025
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors...
K250326 · KFM
Spectrum Medical S.R.L.
Cardiovascular · 139d
Cleared Jun 20, 2025
MC2™ Two-Stage Venous Cannula
K251258 · DWF
Medtronic, Inc.
Cardiovascular · 58d
Cleared Jun 20, 2025
FloPatch FP120
K251114 · DPW
Flosonics Medical
Cardiovascular · 70d
Cleared Jun 20, 2025
Us2.ca
K250151 · SDJ
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Cardiovascular · 150d
Cleared Jun 20, 2025
Celsi Warmer
K242964 · DWJ
Hadleigh Health Technologies
Cardiovascular · 267d
Cleared Jun 18, 2025
FlexiGo 3D Delivery Catheter
K250492 · DQY
CenterPoint Systems, LLC
Cardiovascular · 118d
Cleared Jun 17, 2025
Dorado™ PTA Balloon Dilatation Catheter
K250219 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 144d
Cleared Jun 17, 2025
VitalSigns 1-Lead Holter (VSH101)
K243003 · DXH
VitalSigns Technology Co., Ltd.
Cardiovascular · 264d
Cleared Jun 15, 2025
Bioptimal Bipolar Pacing Catheter
K242863 · LDF
Bioptimal International Pte. , Ltd.
Cardiovascular · 268d
Cleared Jun 15, 2025
Withings ECG App
K240795 · QDA
Withings
Cardiovascular · 450d