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
1489–1512 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared CT Feb 09, 2022
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire,...
K212167 · DQX
Vascular Solutions, LLC
Cardiovascular · 212d
Cleared Feb 08, 2022
AcQCross Qx Integrated Transseptal Dilator/Needle
K220047 · DYB
Acutus Medical, Inc.
Cardiovascular · 34d
Cleared Feb 08, 2022
PathBuilder Steerable Introducer
K211530 · DYB
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 267d
Cleared Feb 03, 2022
LifePath Remote Patient Monitoring Platform
K211822 · DRG
Elastic Care Incorporated
Cardiovascular · 234d
Cleared Feb 01, 2022
JETi AIO Peripheral Thrombectomy System
K213565 · QEZ
Walk Vascular, LLC
Cardiovascular · 84d
Cleared Feb 01, 2022
Infinity Acute Care System (IACS) Monitoring System
K203088 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 476d
Cleared Jan 28, 2022
QuikPass Catheter
K214106 · DQY
Traverse Vascular, Inc.
Cardiovascular · 30d
Cleared Jan 28, 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U,...
K212341 · DTZ
Qura S.R.L
Cardiovascular · 184d
Cleared Jan 27, 2022
Merlin Aspiration System
K213771 · DXE
Mivi Neurovascular, Inc.
Cardiovascular · 56d
Cleared Jan 27, 2022
RA-T59 Wrist blood pressure monitor
K212312 · DXN
Lotusnine Medical Limited
Cardiovascular · 188d
Cleared Jan 27, 2022
9Line
K211941 · DSA
Energetic Designs, Inc.
Cardiovascular · 218d
Cleared Jan 27, 2022
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek...
K211589 · DPW
Remington Medical, Inc.
Cardiovascular · 248d
Cleared Jan 26, 2022
LASSOSTAR NAV Circular Mapping Catheter
K211219 · DRF
Biosense Webster, Inc.
Cardiovascular · 278d
Cleared Jan 19, 2022
Biotres
K211709 · MWJ
Biotricity
Cardiovascular · 230d
Cleared Jan 19, 2022
Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
K211532 · DXN
Yibin Junxin Electronics Technology...
Cardiovascular · 246d
Cleared Jan 14, 2022
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
K213593 · OBJ
Boston Scientific Corporation
Cardiovascular · 63d
Cleared Jan 14, 2022
Capsule Surveillance System
K213335 · MWI
Capsule Surveillance Technologies,...
Cardiovascular · 100d
Cleared Jan 14, 2022
Bio-Medicus Life Support Catheter and Introducer
K201057 · QHW
Medtronic, Inc.
Cardiovascular · 633d
Cleared Jan 12, 2022
BIB Stent Placement Catheter
K213915 · NVM
NuMED, Inc.
Cardiovascular · 28d
Cleared Jan 12, 2022
Arm Blood Pressure Monitor
K212877 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 125d
Cleared Jan 11, 2022
Cardiovascular Suite 4.2.1
K202094 · DQK
Quipu S.R.L
Cardiovascular · 532d
Cleared Jan 10, 2022
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat...
K212688 · DTR
Qura S.R.L
Cardiovascular · 138d
Cleared Jan 07, 2022
Prelude IDeal 9F Hydrophilic Sheath Introducer
K212152 · DYB
Merit Medical Systems
Cardiovascular · 182d
Cleared Jan 07, 2022
Selebrek PTCA Balloon Dilatation Catheter
K211349 · LOX
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 249d