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
793–816 of 18,110
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