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
1825–1848 of 18,182
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