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
625–648 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 03, 2024
ShapeIT (SI014135)
K241611 · DQY
Imds Operations B.V.
Cardiovascular · 90d
Cleared Aug 30, 2024
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K241583 · DPW
Remington Medical, Inc.
Cardiovascular · 88d
Cleared Aug 29, 2024
RHYTHMIA HDx™ Mapping System
K241227 · DQK
Boston Scientific Corporation
Cardiovascular · 119d
Cleared Aug 28, 2024
Fogarty Thru-Lumen Embolectomy Catheter
K240078 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 230d
Cleared Aug 27, 2024
Isolator Synergy EnCapture Ablation System (EMH)
K234151 · OCL
AtriCure, Inc.
Cardiovascular · 242d
Cleared Aug 26, 2024
TriClip Steerable Guide Catheter
K241538 · DQY
Abbott Medical
Cardiovascular · 88d
Cleared Aug 23, 2024
Morph DNA Steerable Introducer Sheath
K242169 · DYB
Biocardia
Cardiovascular · 30d
Cleared Aug 22, 2024
Introducer Sheath Kits
K242248 · DYB
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 22d
Cleared Aug 21, 2024
Blood Pressure Monitor (TMB-2092-G)
K241351 · DXN
Guangdong Transtek Medical...
Cardiovascular · 100d
Cleared Aug 21, 2024
Glidewire GT-R
K240859 · DQX
Terumo Corporation
Cardiovascular · 146d
Cleared Aug 16, 2024
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT...
K242239 · NQQ
Gentuity, LLC
Cardiovascular · 17d
Cleared Aug 16, 2024
XTRA Collection sets
K241236 · CAC
Sorin Group Italia S.R.L.
Cardiovascular · 106d
Cleared Aug 16, 2024
HeartKey® Rhythm
K233755 · DQK
B-Secur Limited
Cardiovascular · 268d
Cleared Aug 16, 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 290d
Cleared Aug 15, 2024
Sapphire ULTRA Coronary Dilatation Catheter
K233505 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 289d
Cleared Aug 14, 2024
CROSSLEAD Tracker
K241510 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 77d
Cleared Aug 14, 2024
Catapult Guide Sheath
K240957 · DYB
Contract Medical International, GmbH
Cardiovascular · 128d
Cleared Aug 09, 2024
EnSite™ X EP System
K242016 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Aug 08, 2024
Masimo W1
K240229 · DPS
Masimo Corporation
Cardiovascular · 192d
Cleared Aug 08, 2024
SMARxT Tubing and Connectors
K233702 · DWE
LivaNova USA, Inc.
Cardiovascular · 265d
Cleared Aug 07, 2024
Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · MTD
Medtronic
Cardiovascular · 300d
Cleared Aug 06, 2024
Abiomed 14Fr Low Profile Introducer Kit
K241708 · DYB
Abiomed, Inc.
Cardiovascular · 54d
Cleared Aug 02, 2024
Samsung ECG App v 1.3 (ECG)
K240909 · QDA
Samsung Electronics Co., Ltd.
Cardiovascular · 122d
Cleared Aug 02, 2024
Acumen Assisted Fluid Management (AFM) Software Feature
K233984 · QMS
Edwards Lifesciences, LLC
Cardiovascular · 228d