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
1513–1536 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 30, 2021
AngioVac F18 85
K212386 · DWF
AngioDynamics, Inc.
Cardiovascular · 59d
Cleared Sep 30, 2021
Philips MR Patient Care Portal
K212227 · MWI
Invivo Corporation
Cardiovascular · 76d
Cleared Sep 30, 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208 · DXJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 77d
Cleared Sep 27, 2021
Amplatzer Talisman Delivery Sheath
K212738 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Sep 27, 2021
Amplatzer Steerable Delivery Sheath
K212026 · DQY
Abbott Medical
Cardiovascular · 90d
Cleared Sep 24, 2021
ViperCross Support Catheters
K212725 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 28d
Cleared Sep 23, 2021
Halo One Thin-Walled Guiding Sheath
K212708 · DYB
C.R. Bard, Inc.
Cardiovascular · 28d
Cleared Sep 23, 2021
Reusable NIBP Cuff
K211747 · DXQ
Shenzhen Coreray Technology Co., Ltd.
Cardiovascular · 108d
Cleared Sep 23, 2021
Automatic Digital Blood Pressure Monitor
K210152 · DXN
Aviche Shandong Medical Technology...
Cardiovascular · 245d
Cleared Sep 22, 2021
SimpleSENSE Platform
K212160 · DXH
Nanowear, Inc.
Cardiovascular · 72d
Cleared Sep 21, 2021
Dayspring Lite
K212287 · JOW
Koya Medical, Inc.
Cardiovascular · 62d
Cleared Sep 16, 2021
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K203111 · DTZ
Medtronic
Cardiovascular · 336d
Cleared Sep 15, 2021
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
K211276 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Sep 14, 2021
Rotarex Atherectomy System
K211738 · MCW
C.R. Bard, Inc.
Cardiovascular · 99d
Cleared Sep 14, 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
K211494 · DRF
Boston Scientific Corporation
Cardiovascular · 124d
Cleared Sep 14, 2021
ANNE One
K211305 · DRG
Sibel, Inc.
Cardiovascular · 138d
Cleared Sep 14, 2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth...
K210586 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 200d
Cleared Sep 10, 2021
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
K211375 · DRF
Boston Scientific Corporation
Cardiovascular · 129d
Cleared Sep 10, 2021
AlertWatch:AC
K210160 · MSX
Alertwatch, Inc.
Cardiovascular · 232d
Cleared Sep 08, 2021
CIRCUL8 Luxe DVT Prevention Device
K211235 · JOW
Ortho8, Inc.
Cardiovascular · 135d
Cleared Sep 08, 2021
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
K211127 · DXN
Health & Life Co., Ltd.
Cardiovascular · 145d
Not Cleared Sep 08, 2021
FEops HEARTguide
DEN200030 · QQI
Feops NV
Cardiovascular · 489d
Cleared Sep 07, 2021
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
K202049 · DXE
Applied Medical Resources Corporation
Cardiovascular · 410d
Cleared Sep 03, 2021
WoundExpress
K211200 · JOW
Huntleigh Healthcare , Ltd.
Cardiovascular · 134d