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
1993–2016 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 06, 2020
MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F...
K192283 · DRE
Medron, LLC
Cardiovascular · 258d
Cleared May 04, 2020
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical...
K200871 · QEZ
Control Medical Technology
Cardiovascular · 33d
Cleared May 01, 2020
Carnation Ambulatory Monitor
K200870 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Apr 30, 2020
PulsioFlex Monitoring System with ProAQT Sensor
K192169 · DXG
Pulsion Medical Systems SE
Cardiovascular · 265d
Cleared Apr 27, 2020
WOLF Thrombectomy V System
K200101 · QEW
Devoro Medical, Inc.
Cardiovascular · 101d
Cleared Apr 25, 2020
Gatekeeper Balloon Catheter
K192786 · MJN
Arch Catheter, LLC
Cardiovascular · 208d
Cleared Apr 23, 2020
Biomonitor III, Biomonitor IIIm
K200444 · MXD
Biotronik, Inc.
Cardiovascular · 59d
Cleared CT Apr 22, 2020
Indigo Aspiration System Lightning Aspiration Tubing
K200771 · QEW
Penumbra, Inc.
Cardiovascular · 28d
Cleared Apr 21, 2020
Instylla Microcatheter
K200744 · KRA
Instylla, Inc.
Cardiovascular · 29d
Cleared Apr 21, 2020
Globalcare Blood Pressure Monitor
K192609 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 214d
Cleared Apr 20, 2020
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit,...
K193343 · DRG
Vitalconnect, Inc.
Cardiovascular · 139d
Cleared Apr 20, 2020
QuickClear Mechanical Thrombectomy System
K193197 · QEZ
Volcano Atheromed, Inc.
Cardiovascular · 152d
Cleared Apr 17, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
K200733 · ITX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Apr 16, 2020
Philips Biosensor BX100
K192875 · DRG
Philips Medical Systems
Cardiovascular · 191d
Cleared Apr 15, 2020
Serranator PTA Serration Balloon Catheter
K193181 · PNO
Cagent Vascular, LLC
Cardiovascular · 149d
Cleared Apr 13, 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal...
K192850 · KFM
Qura S.R.L
Cardiovascular · 193d
Cleared Apr 13, 2020
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium...
K192838 · DWA
Spectrum Medical , Ltd.
Cardiovascular · 193d
Cleared Apr 09, 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
K200634 · DSP
Arrow International, Inc.
Cardiovascular · 30d
Cleared Apr 09, 2020
Unified Arrhythmia Diagnostic System PocketECG IV
K193104 · DSI
Medicalgorithmics S.A.
Cardiovascular · 153d
Cleared Apr 09, 2020
Nautilus Smart ECMO Module
K191935 · BYS
Mc3 Incorporated
Cardiovascular · 265d
Cleared Apr 08, 2020
HI-TORQUE Steelcore Bare Guide Wire
K200144 · DQX
Abbott Vascular
Cardiovascular · 77d
Cleared Apr 08, 2020
Go2Wire Guide Wire
K193571 · DQX
Merit Medical System, Inc.
Cardiovascular · 107d
Cleared Apr 06, 2020
Eko CORE
K200776 · DQD
Eko Devices, Inc.
Cardiovascular · 12d
Cleared Apr 06, 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K192500 · DXQ
Honsun (Nantong) Co., Ltd.
Cardiovascular · 207d