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
1105–1128 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 30, 2023
Excipio SV Aspiration Catheter and Tubing
K230030 · QEW
Contego Medical, Inc.
Cardiovascular · 145d
Cleared May 30, 2023
PrecisionTAVI (v1.1)
K223809 · QQI
Dasi Simulations
Cardiovascular · 161d
Cleared May 26, 2023
WellsForm Tricuspid Annuloplasty Band (WF)
K230679 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 74d
Cleared May 26, 2023
Finesse™ Injectable PTA Balloon Dilatation Catheter
K230263 · LIT
Summa Therapeutics, LLC
Cardiovascular · 115d
Cleared May 26, 2023
CORE 500 Digital Stethoscope
K230111 · DQD
Eko Devices, Inc.
Cardiovascular · 129d
Cleared May 25, 2023
Stingray LP Catheter
K231176 · DQY
Boston Scientific
Cardiovascular · 30d
Cleared May 25, 2023
Saranas Early Bird Bleed Monitoring System
K230273 · QFJ
Saranas, Inc.
Cardiovascular · 114d
Cleared May 25, 2023
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
K222311 · FLL
Circa Scientific, Inc.
Cardiovascular · 297d
Cleared May 22, 2023
Kodiak™ Dual Port Coaxial Introducer Kit
K230631 · DYB
Argon Medical Devices
Cardiovascular · 76d
Cleared May 19, 2023
BIOMONITOR IV
K230375 · MXD
Biotronik, Inc.
Cardiovascular · 95d
Cleared May 19, 2023
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
K222979 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 233d
Cleared May 19, 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors,...
K220842 · KFM
Qura S.R.L
Cardiovascular · 422d
Cleared May 18, 2023
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging...
K230453 · OBJ
Boston Scientific Corporation
Cardiovascular · 86d
Cleared May 17, 2023
Assert-IQ™ Insertable Cardiac Monitor
K230286 · MXC
Abbott Medical
Cardiovascular · 104d
Cleared May 16, 2023
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · MMX
Cook Incorporated
Cardiovascular · 293d
Cleared May 15, 2023
HD+12, HD+15
K220526 · DRG
Cardioline S.P.A
Cardiovascular · 445d
Cleared May 05, 2023
Wattson temporary pacing guidewire (2250)
K230637 · DQX
Vascular Solutions, LLC
Cardiovascular · 59d
Cleared May 05, 2023
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model...
K222926 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 221d
Cleared May 04, 2023
DLP™ Silicone Coronary Artery Ostial Cannulae
K230960 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 03, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · OWQ
Abbott Medical
Cardiovascular · 30d
Cleared May 03, 2023
FloPatch FP120
K223843 · DPW
Flosonics Medical
Cardiovascular · 132d
Cleared May 02, 2023
TriSalus TriNav® LV Infusion System
K230957 · KRA
Trisalus Life Sciences
Cardiovascular · 28d
Cleared May 02, 2023
Artix BG
K230912 · QEW
Inari Medical
Cardiovascular · 32d
Cleared May 02, 2023
AcQMap® High Resolution Imaging and Mapping System
K230606 · DQK
Acutus Medical, Inc.
Cardiovascular · 60d