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
961–984 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 10, 2023
ANNE One
K223711 · DRG
Sibel Health, Inc.
Cardiovascular · 241d
Cleared Aug 08, 2023
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
K230620 · DQO
Gentuity, LLC
Cardiovascular · 155d
Cleared Aug 08, 2023
Rubicon™ Control Support Catheter (H749394323506A1)
K223633 · DQY
Boston Scientific Corporation
Cardiovascular · 246d
Cleared Aug 07, 2023
Reprocessed Agilis NxT Steerable Introducer
K230376 · PNE
Innovative Health, LLC
Cardiovascular · 175d
Cleared Aug 04, 2023
LEGACY® IPC
K232006 · JOW
Ig Technology, Ltd.
Cardiovascular · 29d
Cleared Aug 04, 2023
ECGenius System
K223787 · DQK
Cath Vision Aps
Cardiovascular · 228d
Cleared Aug 03, 2023
LifeSPARC System
K232132 · KFM
Cardiacassist, Inc.
Cardiovascular · 16d
Not Cleared Aug 03, 2023
Viz HCM
DEN230003 · QXO
Viz. Ai, Inc.
Cardiovascular · 205d
Cleared Aug 02, 2023
BPBIO750
K231174 · DXN
Inbody Co., Ltd.
Cardiovascular · 99d
Cleared Aug 02, 2023
SKEEPER
K230613 · DQD
Smartsound Corporation
Cardiovascular · 149d
Cleared Aug 01, 2023
Nuubo Smart
K231620 · DQK
Smart Solutions Technologies SL
Cardiovascular · 60d
Cleared Jul 31, 2023
CNS-2101 Central Monitor
K223567 · MSX
Nihon Kohden Corporation
Cardiovascular · 244d
Cleared Jul 28, 2023
MESI mTablet ECG Diagnostic System, MESI mTablet ECG
K223670 · DPS
Mesi, Development of Medical Devices,...
Cardiovascular · 233d
Cleared Jul 28, 2023
Electrocardiograph: SE-1200 Pro and SE-1201 Pro
K222902 · DPS
Edan Instruments, Inc.
Cardiovascular · 308d
Cleared Jul 27, 2023
R2P Navicross
K231044 · DQY
Terumo Medical Corporation
Cardiovascular · 106d
Cleared Jul 26, 2023
Global Hypoperfusion Index (GHI) Algorithm
K231038 · QNL
Edwards Lifesciences, LLC
Cardiovascular · 105d
Cleared Jul 26, 2023
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
K222994 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 301d
Cleared Jul 25, 2023
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
K231621 · OWQ
Stryker Sustainability Solutions
Cardiovascular · 53d
Cleared Jul 21, 2023
Triever20 Curve (21-201)
K231848 · QEW
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Jul 21, 2023
Irregular Rhythm Notification Feature (IRNF)
K231173 · QDB
Apple, Inc.
Cardiovascular · 87d
Cleared Jul 21, 2023
Firefighter™ NC Pro PTCA Balloon Catheter
K223189 · LOX
Shanghai MicroPort Medical (Group)...
Cardiovascular · 282d
Cleared Jul 20, 2023
CROSSLEAD Penetration Peripheral Guide Wire
K230377 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 157d
Cleared Jul 14, 2023
FlowSaver Blood Return System (80-101)
K231782 · CAC
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Jul 14, 2023
TalWire
K223791 · DQX
Embrace Medical , Ltd.
Cardiovascular · 207d