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
457–480 of 18,182
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 CT 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 CT Jun 15, 2025
Withings ECG App
K240795 · QDA
Withings
Cardiovascular · 450d