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
1033–1056 of 18,110
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