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
3361–3384 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 17, 2015
MoMe Software Platform
K152491 · DSI
Infobionic, Inc.
Cardiovascular · 107d
Cleared Dec 17, 2015
Renew NCP-5 External Counterpulsation System
K152115 · DRN
Stage 2 Innovations
Cardiovascular · 141d
Cleared Dec 17, 2015
Bpump Blood Pressure Cuff
K151810 · DXQ
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 168d
Cleared Dec 16, 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153450 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 16d
Cleared Dec 16, 2015
Advanced Perfusion System 1
K153376 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 23d
Cleared Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire,...
K151840 · DQX
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Dec 16, 2015
Vios Monitoring System
K150992 · DRT
Vios Medical, Inc.
Cardiovascular · 245d
Cleared Dec 16, 2015
XM-01 Electronic Automatic Blood Pressure Monitor
K150908 · DXN
Sky Innovation Technology ( Shanghai)...
Cardiovascular · 257d
Cleared Dec 16, 2015
PulseFlowDF
K150806 · JOW
Pulseflow Technologies
Cardiovascular · 265d
Cleared Dec 15, 2015
Monitor B40
K151063 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 239d
Cleared Dec 14, 2015
ViSi Mobile Monitoring System
K152341 · MWI
Sotera Wireless, Inc.
Cardiovascular · 117d
Cleared Dec 14, 2015
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate...
K152202 · DQY
Tni Manufacturing, Inc.
Cardiovascular · 130d
Cleared Dec 14, 2015
AbStats Gateway
K150782 · DQD
Gi Logic, Inc.
Cardiovascular · 264d
Cleared Dec 11, 2015
LC Bead LUMI
K152157 · KRD
Biocompatibles UK , Ltd.
Cardiovascular · 130d
Cleared Dec 10, 2015
ALP VasQcare Take Home System
K151158 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 223d
Cleared Dec 10, 2015
Checkme Pro Health Monitor
K150869 · MWI
Viatom Technology Co., Ltd.
Cardiovascular · 253d
Cleared Dec 09, 2015
MIVI Mi-AXUS Guide Catheter
K151396 · DQY
Mivi Neuroscience, Inc.
Cardiovascular · 197d
Cleared Dec 08, 2015
higi Station
K151127 · DXN
Higi Sh, LLC
Cardiovascular · 224d
Cleared Dec 07, 2015
Houdini Catheter
K151896 · DQY
Cruzar Medsystems, Inc.
Cardiovascular · 150d
Cleared Dec 06, 2015
Vital Connect Platform, HealthPatch MD, VitalPatch
K152139 · DRG
Vitalconnect, Inc.
Cardiovascular · 125d
Cleared Dec 04, 2015
Stingray LP Catheter
K152401 · DQY
Boston Scientific Corporation
Cardiovascular · 101d
Cleared Dec 04, 2015
Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
K151936 · DYB
Synaptic Medical Limited
Cardiovascular · 143d
Cleared Dec 03, 2015
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
K153213 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 28d
Cleared Dec 03, 2015
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · DSK
Volcano Corporation
Cardiovascular · 84d