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
1585–1608 of 18,182
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