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
865–888 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 16, 2024
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
K233708 · DYB
Synaptic Medical Corporation
Cardiovascular · 88d
Cleared Feb 15, 2024
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere...
K233483 · MCW
Cardio Flow Inc.,
Cardiovascular · 111d
Cleared Feb 13, 2024
Easi-Vue® embolic microspheres System
K234123 · KRD
Abk Biomedical, Inc.
Cardiovascular · 47d
Cleared Feb 13, 2024
EPi-Ease Epicardial Access Device (EAS)
K233959 · DYB
AtriCure, Inc.
Cardiovascular · 60d
Cleared Feb 09, 2024
VenaCore Thrombectomy Catheter (46-101)
K234034 · QEW
Inari Medical, Inc.
Cardiovascular · 51d
Cleared Feb 09, 2024
Neteera 130H-Plus Vital Sign Monitoring Sensor
K231733 · DRT
Neteera Technologies , Ltd.
Cardiovascular · 241d
Cleared Feb 08, 2024
SINC Support Catheter
K233350 · DQY
Reflow Medical, Inc.
Cardiovascular · 132d
Cleared Feb 05, 2024
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A,...
K233895 · DWF
Edwards Lifesciences
Cardiovascular · 56d
Cleared Feb 05, 2024
Central Monitoring System (MFM-CMS)
K232694 · MHX
Edan Instruments, Inc.
Cardiovascular · 153d
Cleared Feb 02, 2024
Indigo® Aspiration System - Lightning® Flash
K240030 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Feb 02, 2024
VitalDetect
K231625 · FLL
Wellvii, Inc.
Cardiovascular · 245d
Cleared Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
K240018 · DQY
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jan 31, 2024
CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S )
K240004 · DYB
Circa Scientific, Inc.
Cardiovascular · 29d
Cleared Jan 28, 2024
Gem Flow Now (GEM2770-FN)
K233394 · IYN
Synovis Micro Companies Alliance
Cardiovascular · 117d
Cleared Jan 26, 2024
CentriMag™ Acute Circulatory Support System
K234118 · QNR
Abbott Medical
Cardiovascular · 29d
Cleared Jan 26, 2024
Arm-type Fully Automatic Digital Blood Pressure Monitor
K231303 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 266d
Cleared Jan 19, 2024
LifeSPARC System
K233736 · QNR
Cardiacassist, Inc.
Cardiovascular · 58d
Cleared Jan 19, 2024
Cleaner™ Pro Thrombectomy System
K232679 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 140d
Cleared Jan 18, 2024
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach...
K233680 · DTK
William Cook Europe Aps
Cardiovascular · 63d
Cleared Jan 18, 2024
Radial Compression Device
K232577 · DXC
Ningbo Dizegens Medical Science Co.,Ltd
Cardiovascular · 146d
Cleared Jan 17, 2024
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
K233783 · DSY
Peca Labs, Inc.
Cardiovascular · 51d
Cleared Jan 13, 2024
CLEWICU System
K233216 · QNL
Clew Medical , Ltd.
Cardiovascular · 107d
Cleared Jan 09, 2024
GORE® PROPATEN® Vascular Graft
K232312 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 160d
Cleared Jan 07, 2024
Lifetech Cardio Temporary Pacemaker
K232721 · DTE
Shenzhen Lifetech Cardio Medical...
Cardiovascular · 124d