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
889–912 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 25, 2023
SignalHF (IM008)
K230842 · QNL
Implicity, Inc.
Cardiovascular · 211d
Cleared Oct 24, 2023
FilteredFlo Warming Blankets
K232638 · DWJ
Iob Medical, Inc.
Cardiovascular · 55d
Cleared Oct 24, 2023
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360...
K232584 · OWQ
Vein 360, LLC
Cardiovascular · 60d
Cleared Oct 24, 2023
Steerant™ Super Stiff Guidewire
K232570 · DQX
Medtronic Vascular
Cardiovascular · 61d
Cleared Oct 24, 2023
Acumen IQ finger cuff
K230919 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 204d
Cleared Oct 23, 2023
PICOCLAMP
K230281 · DXC
Kono Seisakusho Co., Ltd.
Cardiovascular · 264d
Cleared Oct 17, 2023
Infinity CentralStation Wide, Infinity M300, Infinity M300+
K231477 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 148d
Cleared Oct 12, 2023
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
K232852 · DXF
Cross Vascular, Inc.
Cardiovascular · 28d
Cleared Oct 12, 2023
ValvuloPro Valvuloplasty Balloon Catheter
K231814 · OZT
Dongguan TT Medical, Inc.
Cardiovascular · 113d
Cleared Oct 12, 2023
Stethophone
K231551 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 135d
Cleared Oct 11, 2023
VASSALLO GT 018 G12
K232578 · DQX
Filmec Co. , Ltd.
Cardiovascular · 47d
Cleared Oct 11, 2023
VASSALLO GT Crossing14
K232574 · DQX
Filmec Co. , Ltd.
Cardiovascular · 47d
Cleared Oct 11, 2023
Arm Blood Pressure Monitor
K231050 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 181d
Cleared Oct 06, 2023
ProtekDuo Veno-Venous Cannula Sets
K232480 · PZS
Cardiacassist, Inc.
Cardiovascular · 51d
Cleared Oct 06, 2023
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
K230265 · DSI
Infobionic, Inc.
Cardiovascular · 248d
Cleared Oct 06, 2023
Vivio® LVEDP System
K223905 · QUO
Avicena, LLC
Cardiovascular · 282d
Cleared Oct 04, 2023
The IQoolTM System
K232844 · DWJ
Braincool AB
Cardiovascular · 20d
Cleared Oct 04, 2023
Nautilus VF ECMO Oxygenator
K232767 · BYS
Mc3, Inc.
Cardiovascular · 23d
Cleared Sep 29, 2023
Amulet™ Steerable Delivery Sheath
K232690 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Sep 29, 2023
BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K232651 · DRF
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Sep 29, 2023
Microcatheter
K232647 · DQY
Surmodics,Inc.
Cardiovascular · 29d
Cleared Sep 29, 2023
Boppli Infant Blood Pressure Monitor
K223873 · DXN
Pyrames, Inc.
Cardiovascular · 280d
Cleared Sep 28, 2023
Low Ejection Fraction AI-ECG Algorithm
K232699 · QYE
Anumana, Inc.
Cardiovascular · 23d
Cleared Sep 27, 2023
Volta AF-Xplorer
K232616 · DQK
Volta Medical
Cardiovascular · 30d