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
3073–3096 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 27, 2016
Torcon NB Advantage Catheters
K161822 · DQO
Cook Incorporated
Cardiovascular · 118d
Cleared Oct 27, 2016
CorPath GRX System
K160121 · DXX
Corindus, Inc.
Cardiovascular · 282d
Cleared Oct 26, 2016
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
K161393 · NLH
Innovative Health, LLC
Cardiovascular · 160d
Cleared Oct 26, 2016
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
K160583 · OBJ
Volcano Corporation
Cardiovascular · 239d
Cleared Oct 25, 2016
NIRO-200NX DP
K162117 · MUD
Hamamatsu Photonics K.K.
Cardiovascular · 88d
Cleared Oct 25, 2016
Tempo Temporary Pacing Lead
K160260 · LDF
Biotrace Medical, Inc.
Cardiovascular · 267d
Cleared Oct 24, 2016
Automatic Arm Bluetooth Blood Pressure Monitor
K161846 · DXN
Truly Instrument Limited
Cardiovascular · 111d
Cleared Oct 24, 2016
Caremed patient cable and leadwires
K153188 · DSA
Shenzhen Caremed Medical Technology...
Cardiovascular · 356d
Cleared Oct 21, 2016
TRAcelet Compression Device
K162027 · DXC
Medtronic Vascular
Cardiovascular · 91d
Cleared Oct 21, 2016
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
K160187 · DQK
St Jude Medical
Cardiovascular · 268d
Cleared Oct 20, 2016
Fluent inflation device
K162272 · MAV
Vascular Solutions, Inc.
Cardiovascular · 69d
Cleared Oct 19, 2016
Tyto Stethoscope
K160401 · DQD
Tyto Care , Ltd.
Cardiovascular · 250d
Cleared Oct 18, 2016
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
K162326 · MCW
Avinger, Inc.
Cardiovascular · 60d
Cleared Oct 18, 2016
Medtronic Temporary External Pacemaker 53401
K162054 · DTE
Medtronic, Inc.
Cardiovascular · 85d
Cleared Oct 18, 2016
ClearLumen II Thrombectomy System
K161786 · QEZ
Walk Vascular, LLC
Cardiovascular · 111d
Cleared Oct 18, 2016
ENROUTE 0.014 Guidewire
K160643 · DQX
Lake Region Medical
Cardiovascular · 225d
Cleared Oct 18, 2016
EasyMap MAP Catheter
K151139 · DRF
Medfact Engineering GmbH
Cardiovascular · 538d
Cleared Oct 14, 2016
VascuCel
K162579 · DXZ
Admedus Regen Pty, Ltd.
Cardiovascular · 29d
Cleared Oct 14, 2016
Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure...
K161886 · DXN
Guangdong Transtek Medical...
Cardiovascular · 95d
Cleared Oct 14, 2016
R2P SlenGuide
K161546 · DQY
Ashitaka Factory of Terumo Corporation
Cardiovascular · 133d
Cleared Oct 14, 2016
HawkOne Directional Atherectomy System
K161361 · MCW
Medtronic Vascular, Inc.
Cardiovascular · 151d
Cleared Oct 13, 2016
Bioflux Software
K162571 · DSH
Biotricity, Inc.
Cardiovascular · 28d
Cleared Oct 13, 2016
Sunmed Haemostatic Valves
K153685 · DQX
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 296d
Cleared Oct 12, 2016
Medtronic Model 5392 External Pulse Generator (EPG)
K162550 · DTE
Medtronic, Inc.
Cardiovascular · 29d