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
1489–1512 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 01, 2021
Electronic Blood Pressure Monitor
K212171 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 112d
Cleared Oct 29, 2021
CARTO 3 EP Navigation System Version 7.2
K213264 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Oct 26, 2021
Thrombuster II Aspiration Catheter
K213166 · QEZ
Kaneka Medical America, LLC
Cardiovascular · 28d
Cleared Oct 22, 2021
IRNF App
K212516 · QDB
Apple, Inc.
Cardiovascular · 73d
Cleared Oct 22, 2021
EnSite X EP System
K212061 · DQK
Abbott
Cardiovascular · 113d
Cleared Oct 21, 2021
XO Cross Support Catheter
K210322 · DQY
Transit Scientific, LLC
Cardiovascular · 259d
Cleared Oct 20, 2021
AVVIGO Guidance System II
K212490 · DQK
Boston Scientific Corporation
Cardiovascular · 72d
Cleared Oct 19, 2021
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
K211084 · DXQ
Shanghai Caremate Medical Device Co.,...
Cardiovascular · 190d
Cleared Oct 19, 2021
WOLF Thrombectomy System, 14F
K210911 · QEW
Devoro Medical, Inc.
Cardiovascular · 204d
Cleared Oct 19, 2021
Capsule Vitals Plus Patient Monitoring System
K210204 · MWI
Capsule Technologie Sas
Cardiovascular · 266d
Cleared Oct 18, 2021
ClotTriever Thrombectomy System
K212632 · QEW
Inari Medical, Inc.
Cardiovascular · 60d
Cleared Oct 15, 2021
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
K212959 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Oct 15, 2021
ViaCath, AcQRate Dx Steerable Catheter
K212593 · DRF
Biotronick, Inc.
Cardiovascular · 60d
Cleared Oct 15, 2021
Arm Blood Pressure Monitor
K210563 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 232d
Cleared Oct 14, 2021
SCORPION Portal Vein Access Set
K213002 · DYB
Argon Medical Devices
Cardiovascular · 24d
Cleared Oct 14, 2021
Sapphire NC 24
K211807 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 125d
Cleared Oct 08, 2021
Carescape SpO2 - Masimo
K212876 · DQA
Masimo Corporation
Cardiovascular · 29d
Cleared Oct 07, 2021
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K212065 · DPW
Remington Medical, Inc.
Cardiovascular · 97d
Cleared Oct 07, 2021
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850,...
K210906 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 195d
Cleared Oct 05, 2021
Vital Signs Monitors
K211475 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 146d
Cleared Oct 05, 2021
Scan Monitor
K201456 · DPS
Withings SA
Cardiovascular · 491d
Cleared Oct 04, 2021
Prelude Guide Sheath
K211405 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 151d
Cleared Oct 01, 2021
electrocardiograph: SE-1202
K210140 · DPS
Edan Instruments, Inc.
Cardiovascular · 255d
Cleared Oct 01, 2021
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
K210139 · DXN
Edan Instruments, Inc.
Cardiovascular · 255d