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
961–984 of 18,182
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