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
433–456 of 18,182
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