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
529–552 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 14, 2025
BB-613-BPM
K241066 · DXN
Biobeat Technologies , Ltd.
Cardiovascular · 271d
Cleared Jan 13, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L,...
K241431 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 237d
Cleared Jan 10, 2025
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269,...
K242528 · DXN
Shenzhen Ruiankang Technology Co., Ltd.
Cardiovascular · 137d
Cleared Jan 10, 2025
Solo Pace Control
K241781 · DTE
Solo Pace, Inc.
Cardiovascular · 204d
Cleared Jan 08, 2025
ANNE View, Central Hub
K242842 · MSX
Sibel Health, Inc.
Cardiovascular · 111d
Cleared Jan 07, 2025
COREPASS Modular Microcatheter (FLEX)
K242588 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 130d
Cleared Dec 31, 2024
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
K243224 · DQY
Abbott Medical
Cardiovascular · 85d
Cleared Dec 23, 2024
PanopticAI Vital Signs
K240890 · QME
PanopticAI technologies Limited
Cardiovascular · 266d
Cleared Dec 20, 2024
KIDS Arterial Filters
K242953 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 86d
Cleared Dec 20, 2024
SENDERO MAX Delivery Catheter
K242644 · DQY
Okami Medical, Inc.
Cardiovascular · 108d
Cleared Dec 20, 2024
Welch Allyn Connex® Spot Monitor
K241411 · MWI
Welch Allyn, Inc.
Cardiovascular · 217d
Cleared Dec 19, 2024
Shadow Catheter
K240885 · DQY
Simpson Interventions, Inc.
Cardiovascular · 262d
Cleared Dec 18, 2024
Falcon/Xpress (Falcon/Xpress)
K242662 · JOP
Viasonix , Ltd.
Cardiovascular · 105d
Cleared Dec 18, 2024
Amethyst HP PTA OTW 0.035 Catheter
K241040 · LIT
Natec Medical , Ltd.
Cardiovascular · 246d
Cleared Dec 17, 2024
Cardiac Workstation (5000)
K241556 · DPS
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 200d
Cleared Dec 16, 2024
TEMBO Embolic System
K240873 · KRD
Instylla, Inc.
Cardiovascular · 262d
Cleared Dec 13, 2024
Agilis NxT Steerable Introducer Dual-Reach
K243493 · DYB
Abbott Medical
Cardiovascular · 31d
Cleared Dec 13, 2024
Laminar P1 (LDH-HW-001)
K242487 · JAF
Laminar Digital Health, Inc.
Cardiovascular · 114d
Cleared Dec 13, 2024
HeartBeam AIMIGo(TM) System
K231424 · MWJ
Heartbeam, Inc.
Cardiovascular · 576d
Cleared Dec 12, 2024
Mac-Lab (AltiX AI.i)
K243540 · DQK
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Dec 10, 2024
Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
K243216 · MWI
Analog Devices
Cardiovascular · 68d
Cleared Dec 10, 2024
Prelude Small O.D. Introducer Guide Wire
K241521 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 195d
Cleared Dec 09, 2024
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)
K242451 · DYG
Edwards Lifesciences
Cardiovascular · 115d
Cleared Dec 06, 2024
PTFE Guidewire
K242824 · DQX
Lake Region Medical
Cardiovascular · 79d