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
2137–2160 of 18,182
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