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
2065–2088 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 04, 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
K192125 · OCL
AtriCure, Inc.
Cardiovascular · 90d
Cleared Oct 31, 2019
ePM Series Patient monitors
K191769 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 122d
Cleared Oct 30, 2019
Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and...
K192775 · PJB
Stereotaxis, Inc.
Cardiovascular · 30d
Cleared Oct 30, 2019
Okami Medical LOBO Vascular Occlusion System
K192083 · KRD
Okami Medical
Cardiovascular · 89d
Cleared Oct 30, 2019
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology...
K191170 · NLH
Innovative Health, LLC
Cardiovascular · 182d
Cleared Oct 30, 2019
EZE SIT Valvulotome
K190267 · MGZ
Lemaitre Vascular
Cardiovascular · 264d
Cleared Oct 27, 2019
EarlyVue VS30
K190624 · DSJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 230d
Cleared Oct 25, 2019
IntellaMap Orion High Resolution Mapping Catheter
K192360 · DRF
Boston Scientific Corporation
Cardiovascular · 56d
Cleared Oct 25, 2019
IOB Warming Blankets
K190221 · DWJ
Iob Medical, Inc.
Cardiovascular · 262d
Cleared Oct 24, 2019
Cronus HP PTA Balloon Catheter
K190037 · LIT
Nipro Medical Corporation
Cardiovascular · 289d
Cleared Oct 18, 2019
Bashir S-B Endovascular Catheter, Ref. No. 7101
K192598 · QEY
Thrombolex, Inc.
Cardiovascular · 28d
Cleared Oct 18, 2019
Confirm Rx Insertable Cardiac Monitor
K192593 · MXC
Abbott
Cardiovascular · 28d
Cleared Oct 17, 2019
Carnation Ambulatory Monitor
K192556 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Oct 17, 2019
WavelinQ Plus EndoAVF System
K192239 · PQK
C.R. Bard, Inc.
Cardiovascular · 59d
Cleared Oct 04, 2019
Steerable Introducer 12F
K192422 · DRA
Freudenberg Medical, LLC
Cardiovascular · 30d
Cleared Oct 04, 2019
Vivio System
K183710 · DQD
Avicena, LLC
Cardiovascular · 277d
Cleared Oct 03, 2019
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
K192318 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 38d
Cleared Oct 01, 2019
Cardioblate CryoFlex Surgical Ablation System
K191526 · OCL
Medtronic, Inc.
Cardiovascular · 113d
Cleared Sep 27, 2019
CATSmart
K192368 · CAC
Fresenius Kabi AG
Cardiovascular · 28d
Cleared Sep 27, 2019
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with...
K191444 · DTZ
Medtronic, Inc.
Cardiovascular · 119d
Cleared Sep 26, 2019
Sterile Dilator
K192195 · DRE
Galt Medical Corp.
Cardiovascular · 44d
Cleared Sep 25, 2019
LifeWindow LW8 Lite
K183687 · MWI
Digicare Biomedical Technology, Inc.
Cardiovascular · 271d
Cleared Sep 24, 2019
Patient Assistant Model PA97000
K190574 · DSI
Medtronic, Inc.
Cardiovascular · 202d
Cleared Sep 20, 2019
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
K192332 · QEW
Inari Medical
Cardiovascular · 24d