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
1297–1320 of 18,110
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 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