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
4201–4224 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 26, 2013
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
K132777 · LIT
Ev3, Inc.
Cardiovascular · 21d
Cleared Sep 26, 2013
PRIMI SUPPORT CATHETER
K132701 · DQY
Thermopeutix, Inc.
Cardiovascular · 28d
Cleared Sep 26, 2013
CG+ ARROW JACC POWERED BY ARROW VPS STYLET
K132133 · OBJ
Arrow International (Subsidiary of...
Cardiovascular · 77d
Cleared Sep 26, 2013
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
K132068 · DPS
Philips Medical Systems
Cardiovascular · 85d
Cleared Sep 26, 2013
COSEAL
K131411 · DXC
Jilin Coronado Medical , Ltd.
Cardiovascular · 134d
Cleared Sep 19, 2013
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K132420 · DQY
Reflow Medical
Cardiovascular · 45d
Cleared Sep 17, 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 67d
Cleared Sep 17, 2013
ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
K130232 · DXN
Jinxinbao Electronic Co.,Ltd
Cardiovascular · 231d
Cleared Sep 17, 2013
ANSWATCH WRIST MONITOR MODEL TS-0411
K123130 · DXN
Taiwan Scientific Corporation
Cardiovascular · 348d
Cleared Sep 16, 2013
HEART SYNC
K131494 · MKJ
Heart Sync, Inc.
Cardiovascular · 116d
Cleared Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · KRD
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 13, 2013
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K132175 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 60d
Cleared Sep 13, 2013
CEROX
K131854 · DPW
Or-Nim Medical , Ltd.
Cardiovascular · 84d
Cleared Sep 12, 2013
AUTOMATIC BLOOD PRESSURE MONITOR
K130925 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 162d
Cleared Sep 09, 2013
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
K132073 · DQK
St Jude Medical
Cardiovascular · 68d
Cleared Sep 06, 2013
ALIVECOR HEART MONITOR
K130409 · DPS
AliveCor, Inc.
Cardiovascular · 199d
Cleared Sep 05, 2013
PRESSUREWIRE
K131452 · DXO
St. Jude Medical Systems AB
Cardiovascular · 108d
Cleared Sep 04, 2013
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
K131148 · DYB
Access Scientific, LLC
Cardiovascular · 134d
Cleared Sep 04, 2013
BIOSPACE
K131064 · DXN
Biospace Corporation Limited
Cardiovascular · 141d
Cleared Sep 04, 2013
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
K131044 · DQD
Diacoustic Medical Devices (Pty) , Ltd.
Cardiovascular · 142d
Cleared Aug 30, 2013
MRI PATIENT MONITORING SYSTEM
K132359 · MWI
Invivo Corporation
Cardiovascular · 31d
Cleared Aug 30, 2013
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · QEW
Codman & Shurtleff, Inc.
Cardiovascular · 38d
Cleared Aug 30, 2013
PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3,...
K131558 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 92d
Cleared Aug 30, 2013
HORIZON XVU (FFR)
K123792 · DQX
Mennen Medical , Ltd.
Cardiovascular · 263d