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
3049–3072 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 22, 2016
CXI Support Catheter
K160884 · KRA
Cook Incorporated
Cardiovascular · 236d
Cleared Nov 22, 2016
MRWire Guide Wire
K160594 · DQX
Nano4imaging GmbH
Cardiovascular · 266d
Cleared Nov 21, 2016
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G...
K161700 · OWQ
Sterilmed, Inc.
Cardiovascular · 154d
Cleared Nov 21, 2016
CorSens
K160656 · DXR
Corsens Medical , Ltd.
Cardiovascular · 258d
Cleared Nov 18, 2016
Fully Automatic Electronic Blood Pressure Monitor
K162230 · DXN
Adon Health Co., Ltd.
Cardiovascular · 102d
Cleared Nov 17, 2016
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6)...
K162843 · DWB
Terumo Cardiovascular Systems...
Cardiovascular · 37d
Cleared Nov 17, 2016
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
K162322 · DYB
Access Scientific, LLC
Cardiovascular · 90d
Cleared Nov 17, 2016
InTRAkit
K162097 · DYB
Medtronic Vascular
Cardiovascular · 111d
Cleared Nov 17, 2016
IQvitals Zone
K161909 · MWI
Midmark Corporation
Cardiovascular · 128d
Cleared Nov 15, 2016
Achieve Advance Mapping Catheter
K162892 · DRF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Nov 14, 2016
Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
K160718 · MWI
Covidien
Cardiovascular · 244d
Cleared Nov 10, 2016
Sunmed Control Syringes
K160190 · DXT
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 288d
Cleared Nov 09, 2016
LUCAS 3 Chest Compression System
K161768 · DRM
Jolife AB
Cardiovascular · 135d
Cleared Nov 04, 2016
Pinpoint GT Introducer Needle
K162769 · DYB
C.R. Bard, Inc.
Cardiovascular · 32d
Cleared Nov 04, 2016
CardioInsight Cardiac Mapping System
K162440 · DQK
Cardioinsight Technologies, Inc.
Cardiovascular · 65d
Cleared Nov 04, 2016
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation...
K162350 · LIT
Boston Scientific Corporation
Cardiovascular · 73d
Cleared Nov 04, 2016
SwiftNINJA Microcatheter
K161921 · KRA
Merit Medical Systems, Inc.
Cardiovascular · 114d
Cleared Nov 03, 2016
Electronic Sphygmomanometer
K160349 · DXN
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 269d
Cleared Nov 03, 2016
Intermittent Pneumatic Compression system
K160180 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 281d
Cleared Nov 02, 2016
CARDIOLINE touchECG
K160746 · DPS
Cardioline S.P.A
Cardiovascular · 229d
Cleared Nov 02, 2016
Boosting Catheter
K160561 · DQY
Qxmedical, LLC
Cardiovascular · 247d
Cleared Nov 02, 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed...
K160421 · NLH
Innovative Health, LLC
Cardiovascular · 260d
Cleared Oct 31, 2016
Squirt Fluid Delivery System
K162777 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 28d
Cleared Oct 31, 2016
Disposable Pressure Transducer
K152472 · DRS
Zhejiang Haisheng Medical Device Co.,...
Cardiovascular · 427d