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
1801–1824 of 18,110
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 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 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