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
1753–1776 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 24, 2020
OptoMonitor 3
K202943 · DXO
Opsens, Inc.
Cardiovascular · 55d
Cleared Nov 24, 2020
eKuore One Wireless Electronic Interface for stethoscope
K201742 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 152d
Not Cleared Nov 24, 2020
CADScor System
DEN190047 · QMW
Acarix A/S
Cardiovascular · 386d
Cleared Nov 23, 2020
Confirm Rx Insertable Cardiac Monitor
K202888 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 56d
Cleared Nov 20, 2020
Fortress Introducer Sheath System
K203179 · DYB
Contract Medical International, GmbH
Cardiovascular · 25d
Cleared Nov 20, 2020
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K202042 · OWQ
Innovative Health, LLC
Cardiovascular · 120d
Cleared Nov 20, 2020
MPS 3 ND Myocardial Protection System
K201984 · DTR
Quest Medical, Inc.
Cardiovascular · 126d
Cleared Nov 19, 2020
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360...
K203008 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 49d
Cleared Nov 18, 2020
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
K202821 · QEW
Penumbra, Inc.
Cardiovascular · 55d
Cleared Nov 18, 2020
Pacific Plus PTA Catheter
K202800 · LIT
Medtronic Vascular,Inc(Formerly D.B.A...
Cardiovascular · 56d
Cleared Nov 17, 2020
JETi AIO Peripheral Thrombectomy System
K201998 · QEZ
Walk Vascular, LLC
Cardiovascular · 120d
Cleared Nov 17, 2020
R501 aortic root cannula without vent line, R502 aortic root cannula with...
K200612 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 253d
Cleared Nov 16, 2020
Cordiana Dx16
K201060 · DQK
Cordiana Medical Informatics AG
Cardiovascular · 209d
Cleared Nov 13, 2020
FlexCath Advance Steerable Sheath and Dilator
K202620 · DRA
Medtronic Cryocath, LP
Cardiovascular · 64d
Cleared Nov 13, 2020
CoroFlow Cardiovascular System
K201881 · DQK
Coroventis Research AB
Cardiovascular · 129d
Not Cleared Nov 13, 2020
Acumen Assisted Fluid Management (AFM) Software Feature
DEN190029 · QMS
Edwards Lifesciences
Cardiovascular · 529d
Cleared Nov 12, 2020
NOVA Patient Warming System
K203085 · DWJ
Encompass Group, LLC
Cardiovascular · 30d
Cleared Nov 12, 2020
KardiaAI
K201985 · DQK
AliveCor, Inc.
Cardiovascular · 118d
Cleared Nov 06, 2020
SimpleSENSE
K201669 · DXH
Nanowear, Inc.
Cardiovascular · 140d
Cleared Nov 05, 2020
LOBO Vascular Occlusion System (model LOBO-5)
K203025 · KRD
Okami Medical
Cardiovascular · 34d
Cleared Nov 04, 2020
Monitor B125, Monitor B105
K201941 · MHX
Ge Medical Systems Information...
Cardiovascular · 114d
Cleared Oct 30, 2020
eKuore Pro Series
K203007 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 29d
Cleared Oct 30, 2020
Aulisa Multiple Patient Digital Vital Sign Monitoring System
K202497 · MSX
Taiwan Aulisa Medical Devices...
Cardiovascular · 60d
Cleared Oct 30, 2020
Patent Hemostasis Band (PH Band)
K201695 · DXC
Medical Ingenuities
Cardiovascular · 130d