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
601–624 of 18,182
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