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
3721–3744 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 19, 2014
VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
K132407 · DSI
Lifewatch Technologies , Ltd.
Cardiovascular · 504d
Cleared Dec 18, 2014
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS,...
K142702 · DWJ
Medivance, Inc.
Cardiovascular · 87d
Cleared Dec 18, 2014
CPS Direct MediGuide Enabled outer catheter
K142239 · DQY
St Jude Medical
Cardiovascular · 127d
Cleared Dec 18, 2014
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner...
K142235 · DQY
St Jude Medical
Cardiovascular · 127d
Cleared Dec 18, 2014
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530 · DXX
Stereotaxis, Inc.
Cardiovascular · 192d
Cleared Dec 18, 2014
ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM
K141218 · DQX
Vadiswire Corporation
Cardiovascular · 220d
Not Cleared Dec 18, 2014
AMIGO REMOTE CATHETER SYSTEM
DEN140009 · PJB
Catheter Robotics, Inc.
Cardiovascular · 303d
Cleared Dec 17, 2014
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 142d
Cleared Dec 17, 2014
NANOSTIM INTRODUCER KIT
K140793 · DYB
St. Jude Medical, Inc.
Cardiovascular · 261d
Cleared Dec 17, 2014
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE...
K140536 · DQX
Lake Region Medical
Cardiovascular · 288d
Cleared Dec 16, 2014
Phlebo Press DVT 603
K142772 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 82d
Cleared Dec 16, 2014
MERIT HYDROPHILIC GUIDEWIRE
K141295 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 211d
Cleared Dec 12, 2014
TELESENSE
K142180 · DSI
Scottcare Corporation
Cardiovascular · 126d
Cleared Dec 12, 2014
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
K142081 · DXT
Osprey Medical, Inc.
Cardiovascular · 134d
Cleared Dec 12, 2014
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
K141756 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 165d
Cleared Dec 12, 2014
SUMMED INFLATION DEVICE KIT
K133795 · MAV
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 364d
Cleared Dec 11, 2014
AngioVac Circuit
K142607 · DWE
Angiodynamics
Cardiovascular · 87d
Cleared Dec 10, 2014
DISTAL ACCESS TORQUE DEVICE
K141054 · DQX
Distal Access, LLC
Cardiovascular · 236d
Cleared Dec 09, 2014
Denali Filter System - Femoral Delivery Kit, Denali Filter System -...
K143208 · DTK
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Dec 08, 2014
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
K141795 · MKJ
R & D Batteries, Inc.
Cardiovascular · 158d
Cleared Dec 05, 2014
Passeo-35 PTA Catheter
K142379 · LIT
Biotronik, Inc.
Cardiovascular · 101d
Cleared Dec 05, 2014
CARDIOSPY ECG HOLTER SYSTEMS
K140847 · MLO
Labtech Kft.
Cardiovascular · 246d
Cleared Dec 04, 2014
ActiveCare+SFT
K142728 · JOW
Medical Compressions System (Dbn) , Ltd.
Cardiovascular · 72d
Cleared Dec 04, 2014
RADAR VASCULAR COMPRESSION DEVICE
K142122 · DXC
Advanced Vascular Dynamics
Cardiovascular · 122d