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
1417–1440 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared 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