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
1969–1992 of 18,110
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 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