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
3601–3624 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 02, 2015
OneStep Pediatric CPR Multi-Function Electrode
K150055 · MKJ
Bio-Detek, Inc.
Cardiovascular · 110d
Cleared May 02, 2015
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
K143734 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 123d
Cleared May 01, 2015
Terumo Pump Tubing
K150542 · DWE
Terumo Cardiovascular Systems...
Cardiovascular · 59d
Cleared May 01, 2015
COVA MONITORING SYSTEM
K142087 · MWI
Tosense, Inc.
Cardiovascular · 275d
Cleared Apr 30, 2015
Vitaphone Tele ECG Loop Recorder
K151013 · DXH
Vitasystems GmbH
Cardiovascular · 15d
Cleared Apr 30, 2015
iTClamp50
K150813 · DXC
Innovative Trauma Care, Inc.
Cardiovascular · 34d
Cleared Apr 30, 2015
ViSi Mobile Monitoring System
K150361 · MWI
Sotera Wireless, Inc.
Cardiovascular · 77d
Cleared Apr 29, 2015
OUTBACK Elite Re-Entry Catheter
K150836 · PDU
Cordis Corporation, A Johnson &...
Cardiovascular · 30d
Cleared Apr 29, 2015
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K141984 · DXN
Andon Health Co, Ltd.
Cardiovascular · 282d
Cleared Apr 23, 2015
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches...
K143252 · DQX
Needle Tech Products, Inc.
Cardiovascular · 161d
Cleared Apr 23, 2015
IntraNovo 25 Microcatheter
K142817 · DQO
Texasmedical Technologies, Inc.
Cardiovascular · 206d
Cleared Apr 22, 2015
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels,...
K150235 · DRQ
Boston Scientific Corporation
Cardiovascular · 79d
Cleared Apr 22, 2015
Reverse Medical Micro Vascular Plug System
K150108 · KRD
Reverse Medical Corporation
Cardiovascular · 92d
Cleared Apr 21, 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K143341 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 151d
Cleared Apr 17, 2015
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor
K150430 · DXN
Fudakang Industrial Co., Ltd.
Cardiovascular · 57d
Cleared Apr 17, 2015
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER
K142083 · OZT
C.R. Bard, Inc.
Cardiovascular · 260d
Cleared Apr 16, 2015
Option (TM) ELITE Vena Cava Filter 100cm System
K143405 · DTK
Rex Medical, L.P.
Cardiovascular · 139d
Cleared Apr 16, 2015
QANS (Quantitative Autonomic Nervous System) Monitoring System
K142551 · DPS
Hhssystems, LLC
Cardiovascular · 218d
Cleared Apr 14, 2015
MicroCross Catheter
K143744 · DQY
Roxwood Medical, Inc.
Cardiovascular · 104d
Cleared Apr 14, 2015
Fast Sphyg by Koven
K143332 · DXQ
Koven Technology, Inc.
Cardiovascular · 145d
Cleared Apr 13, 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K150732 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 24d
Cleared Apr 13, 2015
PINPOINT GT SAFETY INTRODUCER NEEDLE
K142445 · DYB
C.R. Bard, Inc.
Cardiovascular · 223d
Cleared Apr 10, 2015
FORE-SIGHT Elite Absolute Tissue Oximeter
K143675 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 107d
Cleared Apr 10, 2015
HEALTH KIOSK
K140360 · DXN
Engagementhealth, LLC
Cardiovascular · 422d