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
1561–1584 of 18,182
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 CT 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 CT 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