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
697–720 of 18,182
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