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
361–384 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 29, 2025
Sleepiz One+ (2.5)
K251364 · DRT
Sleepiz AG
Cardiovascular · 89d
Cleared Jul 29, 2025
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
K250356 · DSI
Infobionic, Inc.
Cardiovascular · 172d
Cleared Jul 29, 2025
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
K250179 · MHX
Edan Instruments, Inc.
Cardiovascular · 188d
Cleared Jul 28, 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
K250652 · QYE
Anumana, Inc.
Cardiovascular · 146d
Cleared Jul 25, 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K250859 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 126d
Cleared Jul 25, 2025
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K250552 · DQX
Abbott Medical
Cardiovascular · 150d
Cleared Jul 24, 2025
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
K252056 · OCL
AtriCure, Inc.
Cardiovascular · 23d
Cleared Jul 23, 2025
MAGiC Sweep™ EP Mapping Catheter
K250590 · DRF
Stereotaxis, Inc.
Cardiovascular · 146d
Cleared Jul 23, 2025
HemoSphere Advanced Monitor (HEM1)
K243781 · DQK
Edwards Lifesciences
Cardiovascular · 226d
Cleared Jul 22, 2025
CardioTag™
K243566 · DXR
Cardiosense, Inc.
Cardiovascular · 246d
Cleared Jul 19, 2025
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
K250913 · OBJ
Jiangsu Tingsn Technology Co., Ltd.
Cardiovascular · 114d
Cleared Jul 17, 2025
DualView Catheter
K250751 · DQO
Terumo Corporation
Cardiovascular · 127d
Cleared Jul 16, 2025
HyperVue™ Software
K251198 · NQQ
Spectrawave, Inc.
Cardiovascular · 90d
Cleared Jul 16, 2025
Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L,...
K251102 · DXN
Cemho Medical Technology (Guangdong)...
Cardiovascular · 96d
Cleared Jul 15, 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 103d
Cleared Jul 15, 2025
Tempus ECG-Low EF
K250119 · QYE
Tempus AI, Inc.
Cardiovascular · 180d
Cleared Jul 14, 2025
FLOWRUNNER Aspiration System
K251488 · QEZ
Expanse Medical, Inc.
Cardiovascular · 61d
Cleared Jul 14, 2025
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19,...
K250185 · DXN
Jiangxi Aicare Medical Technology...
Cardiovascular · 173d
Cleared Jul 13, 2025
Welch Allyn Connex® 360 (Multiple)
K243598
Welch Allyn, Inc.
Cardiovascular · 234d
Cleared Jul 11, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional...
K250772 · NLH
Surgical Instrument Service and...
Cardiovascular · 120d
Cleared Jul 11, 2025
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
K241179 · QYX
Vivaquant, Inc.
Cardiovascular · 438d
Cleared Jul 10, 2025
RAP Femoral Venous Cannulae
K250283 · DWF
LivaNova USA, Inc.
Cardiovascular · 160d
Cleared Jul 10, 2025
ZBPro Diagnostic
K243252 · DPS
Zbeats, Inc.
Cardiovascular · 268d
Cleared Jul 09, 2025
HARBOR Occlusion Device
K250133 · KRD
Nuvascular, Inc.
Cardiovascular · 173d