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
2041–2064 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 06, 2020
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula...
K200306 · DWA
Abbott (Formerly Thoratec Corporation)
Cardiovascular · 29d
Cleared Mar 05, 2020
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
K193147 · PJB
Stereotaxis, Inc.
Cardiovascular · 113d
Cleared Mar 04, 2020
Capere Thrombectomy System
K200314 · QEW
Vascular Medcure, Inc.
Cardiovascular · 27d
Cleared Mar 04, 2020
Sapphire II PRO
K200269 · LOX
Orbusneich Medical Trading, Inc.
Cardiovascular · 29d
Cleared Mar 02, 2020
CARDIOVIT AT-102 G2
K183425 · DPS
Schiller AG
Cardiovascular · 447d
Cleared Feb 28, 2020
Arctic Sun Stat Temperature Management System
K200225 · DWJ
Medivance, Inc.
Cardiovascular · 29d
Cleared Feb 28, 2020
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
K191246 · DTZ
Chalice Medical , Ltd.
Cardiovascular · 295d
Cleared Feb 25, 2020
Heater-Cooler System 3T
K191402 · DWC
Livanova Deutschland, GmbH
Cardiovascular · 277d
Cleared Feb 21, 2020
Upper Arm Blood Pressure Monitor
K191894 · DXN
Shenzhen Zhengkang Technology Co., Ltd.
Cardiovascular · 221d
Cleared Feb 21, 2020
Cardiac Monitor 1500
K191697 · DSB
Zynex Medical, Inc.
Cardiovascular · 241d
Cleared Feb 21, 2020
Novalung System
K191407 · QJZ
Fresenius Medical Care Renal...
Cardiovascular · 269d
Cleared CT Feb 20, 2020
Wingman 14, Wingman 14C, Wingman 18, Wingman 35
K193596 · DQY
Reflow Medical
Cardiovascular · 59d
Cleared Feb 20, 2020
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
K192922 · NQQ
Gentuity, LLC
Cardiovascular · 127d
Cleared Feb 19, 2020
speX Support Catheter
K193012 · DQY
Reflow Medical
Cardiovascular · 113d
Cleared Feb 19, 2020
Sentinel Cerebral Protection System
K192460 · PUM
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Feb 16, 2020
Swan-Ganz Catheters
K193466 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 62d
Cleared Feb 14, 2020
EMBA Hourglass Peripheral Embolization Device (PED)
K200083 · KRD
Embolic Acceleration, LLC
Cardiovascular · 30d
Cleared Feb 11, 2020
AcQMap High Resolution Imaging and Mapping System
K193013 · DQK
Acutus Medical, Inc.
Cardiovascular · 105d
Not Cleared Feb 10, 2020
Surfacer Inside-Out Access Catheter System
DEN190038 · QJH
Bluegrass Vascular Technologies, Inc.
Cardiovascular · 179d
Cleared Feb 06, 2020
VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single,...
K192757 · DRG
Vitalconnect, Inc.
Cardiovascular · 129d
Cleared Feb 04, 2020
The Caterpillar and Caterpillar Micro Arterial Embolization Devices
K191532 · KRD
C.R. Bard, Inc.
Cardiovascular · 239d
Cleared Jan 29, 2020
WVSM (Wireless Vital Signs Monitor) RWC + miniCap
K191989 · MWI
Athena Gtx
Cardiovascular · 188d
Cleared Jan 29, 2020
Ezvena IPC, Ezvena SQS
K191937 · JOW
Eezcare Medical Corp
Cardiovascular · 194d
Cleared Jan 29, 2020
Carescape B850
K191323 · MHX
GE Healthcare Finland Oy
Cardiovascular · 259d