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
1033–1056 of 18,182
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