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
2353–2376 of 18,110
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 Dec 06, 2018
FFRct
K182035 · PJA
HeartFlow, Inc.
Cardiovascular · 129d
Cleared 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 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