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
2425–2448 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 10, 2018
CATSmart
K180831 · CAC
Fresenius Kabi AG
Cardiovascular · 255d
Cleared Dec 07, 2018
Tractus Crossing Support Catheter
K180889 · DQY
Tractus Vascular, LLC
Cardiovascular · 247d
Cleared Dec 06, 2018
Unity Network ID
K183116 · MWI
Ge Healthcare
Cardiovascular · 27d
Cleared CT Dec 06, 2018
FFRct
K182035 · PJA
HeartFlow, Inc.
Cardiovascular · 129d
Cleared CT Dec 06, 2018
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic...
K181529 · LIT
Contego Medical, LLC
Cardiovascular · 178d
Cleared Dec 04, 2018
Coolrail Linear Pen
K183065 · OCL
AtriCure, Inc.
Cardiovascular · 29d
Cleared Nov 30, 2018
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or...
K182245 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 102d
Cleared Nov 30, 2018
Arterial Pressure Monitoring Set/Tray
K180792 · DQO
Cook Incorporated
Cardiovascular · 248d
Cleared Nov 30, 2018
ZOLL Propaq M
K180482 · MHX
ZOLL Medical Corporation
Cardiovascular · 280d
Cleared CT Nov 30, 2018
Prizma
K173589 · DXH
G-Medical Innovations , Ltd.
Cardiovascular · 375d
Cleared Nov 26, 2018
FlexCath Advance Steerable Sheath and Dilator
K183174 · DRA
Medtronic Cryocath, LP
Cardiovascular · 10d
Cleared Nov 26, 2018
Selethru PTCA Balloon Dilatation Catheter
K182699 · LOX
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 60d
Cleared Nov 26, 2018
EkoSonic Endovascular System
K182324 · QEY
Btg International, Inc.
Cardiovascular · 91d
Cleared Nov 23, 2018
Digistat Smart Central
K180430 · MSX
Ascom Ums Srl Unipersonale
Cardiovascular · 280d
Cleared Nov 21, 2018
Heli-FX EndoAnchor System
K182957 · OTD
Medtronic Vascular, Inc.
Cardiovascular · 28d
Cleared Nov 19, 2018
AI-ECG Platform
K180432 · DQK
Shenzhen Carewell Electronics., Ltd.
Cardiovascular · 272d
Cleared Nov 16, 2018
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3...
K182916 · MJN
Lemaitre Vascular
Cardiovascular · 29d
Cleared Nov 16, 2018
PureFlex Arterial Cannulae
K180979 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 217d
Cleared Nov 16, 2018
HemoSphere Advanced Monitor, HemoSphere Pressure Cable
K180881 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 226d
Cleared Nov 15, 2018
CardioBand ECG Event Recorder
K181998 · DPS
Samsung Strategy and Innovation...
Cardiovascular · 112d
Cleared Nov 15, 2018
Reprocessed Marinr Diagnostic EP Catheter
K181897 · NLH
Innovative Health, LLC
Cardiovascular · 122d
Cleared Nov 15, 2018
IntelliVue Multi-Measurement Module MMX
K181831 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 129d
Cleared Nov 14, 2018
Wearable Device
K182543 · MSX
Snap40, Ltd.
Cardiovascular · 58d
Cleared Nov 09, 2018
HEM-6410T-ZM Wrist Blood Pressure Monitor
K182481 · DXN
Omron Healthcare, Inc.
Cardiovascular · 60d