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
1921–1944 of 18,110
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 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