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
1873–1896 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 19, 2020
B&J DVT Calf/Thigh Garments, Models 801/830 Series
K201532 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 103d
Cleared Sep 18, 2020
Tempus Pro Patient Monitor
K201746 · MHX
Remote Diagnostic Technologies Limited
Cardiovascular · 84d
Cleared Sep 18, 2020
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
K201642 · DTZ
Chalice Medical , Ltd.
Cardiovascular · 93d
Cleared Sep 18, 2020
B&J DVT Foot Garments, Models 820 Series
K201547 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 101d
Cleared Sep 18, 2020
SentEP
K192890 · LLZ
Sentiar, Inc.
Cardiovascular · 344d
Cleared Sep 16, 2020
VX1
K201298 · DQK
Volta Medical
Cardiovascular · 124d
Cleared Sep 15, 2020
UNIFUSE Infusion System with Cooper Wire
K202347 · QEY
AngioDynamics, Inc.
Cardiovascular · 28d
Cleared Sep 15, 2020
AcQMap 3D Imaging and Mapping Catheter
K201341 · MTD
Acutus Medical, Inc.
Cardiovascular · 118d
Cleared Sep 15, 2020
Athletis PTA Balloon Dilatation Catheter
K201170 · LIT
Boston Scientific Corporation
Cardiovascular · 137d
Cleared Sep 14, 2020
Feelix Stethoscope
K200862 · DQD
Sonavi Labs, Inc.
Cardiovascular · 166d
Cleared Sep 14, 2020
VIVO
K200313 · DQK
Catheter Precision, Inc.
Cardiovascular · 221d
Cleared Sep 11, 2020
FLEX Vessel Prep System
K202187 · PNO
Venturemed Group, Inc.
Cardiovascular · 38d
Cleared Sep 11, 2020
HotDog Temperature Management Controller
K201779 · DWJ
Augustine Temperature Management
Cardiovascular · 73d
Cleared Sep 11, 2020
SABER .035 PTA Dilatation Catheter
K201333 · LIT
Cordis Corporation
Cardiovascular · 115d
Cleared CT Sep 11, 2020
Fitbit ECG App
K200948 · QDA
Fitbit, Inc.
Cardiovascular · 156d
Cleared Sep 11, 2020
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
K192137 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 401d
Cleared Sep 10, 2020
Tigereye CTO-Crossing Catheter
K201330 · PDU
Avinger, Inc.
Cardiovascular · 114d
Cleared CT Sep 09, 2020
ClotTriever Thrombectomy System
K193462 · QEW
Inari Medical
Cardiovascular · 268d
Cleared Sep 08, 2020
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair...
K202252 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Sep 04, 2020
Astopad Patient Warming System
K202197 · DWJ
Stihler Electronic GmbH
Cardiovascular · 30d
Cleared Sep 03, 2020
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K200212 · MTD
Innovative Health, LLC
Cardiovascular · 219d
Cleared Sep 02, 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal...
K202169 · KFM
Qura S.R.L
Cardiovascular · 30d
Cleared Sep 02, 2020
RX-1 Rhythm Express Remote Cardiac Monitoring System
K200833 · MLO
Vivaquant, Inc.
Cardiovascular · 156d
Cleared Sep 02, 2020
VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE...
K200812 · OBJ
Philips Image Guided Therapy Corporation
Cardiovascular · 159d