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
1369–1392 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 30, 2022
Wrist Type Blood Pressure Monitor
K220651 · DXN
Shenzhen Jamr Medical Technology Co.,...
Cardiovascular · 115d
Cleared Jun 30, 2022
NC TREK NEO Coronary Dilatation Catheter
K220634 · LOX
Abbott Vascular
Cardiovascular · 118d
Cleared Jun 30, 2022
VASSALLO GT 018 Floppy
K213949 · DQX
Filmecc Co., Ltd.
Cardiovascular · 195d
Cleared Jun 30, 2022
Epicardial Access System
K213582 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 230d
Cleared Jun 29, 2022
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model...
K220544 · PDU
Ra Medical Systems,Inc
Cardiovascular · 124d
Cleared Jun 29, 2022
Ebony HP PTA OTW 0.035 Catheter
K220410 · LIT
Natec Medical , Ltd.
Cardiovascular · 135d
Cleared Jun 29, 2022
Eko Murmur Analysis Software (EMAS)
K213794 · DQD
Eko Devices, Inc.
Cardiovascular · 205d
Cleared Jun 28, 2022
Med-link Disposable ECG Cable and Leadwires
K220447 · DSA
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 132d
Cleared Jun 28, 2022
VenAir, Sequential Compression System
K213577 · JOW
Apex Medical Corp.
Cardiovascular · 230d
Cleared Jun 23, 2022
Excipio SV Thrombectomy Device
K221204 · QEW
Contego Medical, Inc.
Cardiovascular · 58d
Cleared Jun 23, 2022
EZYPRO ECG Recorder (Model: UG02)
K213233 · DRG
Sigknow Biomedical Co., Ltd.
Cardiovascular · 266d
Cleared Jun 22, 2022
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry...
K213682 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 212d
Cleared Jun 22, 2022
T3 Platform Software
K213230 · PPW
Etiometry, Inc.
Cardiovascular · 266d
Cleared Jun 21, 2022
Aspirex Thrombectomy System
K220270 · QEW
C.R. Bard, Inc.
Cardiovascular · 141d
Cleared Jun 21, 2022
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K210766 · MTD
Acutus Medical, Inc.
Cardiovascular · 463d
Cleared Jun 17, 2022
Langston dual lumen catheter
K221470 · DQO
Vascular Solutions, LLC
Cardiovascular · 28d
Cleared Jun 17, 2022
CipherOx CRI Tablet
K213255 · PPW
Flashback Technologies, Inc.
Cardiovascular · 260d
Cleared Jun 15, 2022
QardioArm 2
K220106 · DXN
Qardio, Inc.
Cardiovascular · 154d
Cleared Jun 10, 2022
IntellaMap Orion High Resolution Mapping Catheter
K220796 · DRF
Boston Scientific Corporation
Cardiovascular · 84d
Cleared Jun 10, 2022
Extroducer Infusion Catheter System
K213442 · KRA
SmartWise Sweden AB
Cardiovascular · 228d
Cleared Jun 09, 2022
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
K221339 · LIT
Contego Medical, Inc.
Cardiovascular · 31d
Cleared CT Jun 09, 2022
Auryon Atherectomy System
K221077 · MCW
Eximo Medical, Ltd.
Cardiovascular · 58d
Cleared Jun 07, 2022
Infinity Gateway Suite
K203579 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 547d
Cleared Jun 03, 2022
CIRCUL8 Connect DVT Prevention Device
K220761 · JOW
Ortho8, Inc.
Cardiovascular · 80d