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
4897–4920 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 22, 2011
U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
K112216 · DXN
Taidoc Technology Corporation
Cardiovascular · 142d
Cleared Dec 22, 2011
HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
K111159 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 241d
Cleared Dec 21, 2011
TCX-I REMOTE CARE MANAGEMENT SYSTEM
K113493 · DRG
Bl Healthcare, Inc.
Cardiovascular · 26d
Cleared Dec 21, 2011
MYSENSE HEART
K113176 · DSH
Cardiac Science Corporation
Cardiovascular · 54d
Cleared Dec 21, 2011
AUREFLO MONITORING SYSTEM
K112657 · DPW
Transonic Systems, Inc.
Cardiovascular · 99d
Cleared Dec 21, 2011
FUKUDA DENSHI VASERA MODEL VS-1500
K112521 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 112d
Cleared Dec 21, 2011
U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
K112274 · DXN
Taidoc Technology Corporation
Cardiovascular · 135d
Cleared Dec 20, 2011
ELM PTA BALLON DILATATION CATHETER
K113468 · LIT
Creagh Medical, Ltd.
Cardiovascular · 28d
Cleared Dec 19, 2011
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH...
K112587 · DWB
Terumo Cardiovascular Systems Corp.
Cardiovascular · 104d
Cleared Dec 16, 2011
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
K110603 · DXN
I.E.M. GmbH
Cardiovascular · 288d
Cleared Dec 15, 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7...
K113133 · DXT
Medrad, Inc.
Cardiovascular · 52d
Cleared Dec 15, 2011
TEMPUSIC PATIENT MONITOR
K113105 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 56d
Cleared Dec 14, 2011
SMI CARDIOVASCULAR PACH
K112683 · DXZ
Solimas Medical, Inc.
Cardiovascular · 90d
Cleared Dec 14, 2011
TERUMO ASPRIATION CATHETER
K112382 · QEZ
Terumo Medical Corporation
Cardiovascular · 118d
Cleared Dec 14, 2011
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT...
K112203 · DRS
Mirador Biomedical, Inc.
Cardiovascular · 135d
Cleared Dec 14, 2011
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
K111738 · DQY
Trireme Medical, Inc.
Cardiovascular · 176d
Cleared Dec 09, 2011
ATB ADVANCE PTA DILATATION CATHETER
K113300 · LIT
Cook, Inc.
Cardiovascular · 30d
Cleared Dec 09, 2011
NETKONNECT REMOTE NETWORK EXTENSION
K112637 · MHX
Nihon Kohden
Cardiovascular · 91d
Cleared Dec 09, 2011
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
K112513 · LIT
Natec Medical , Ltd.
Cardiovascular · 101d
Cleared Dec 09, 2011
SARN CENTRIFUGAL PUMP
K112229 · KFM
Terumo Cardiovascular Systems
Cardiovascular · 128d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY...
K111830 · DXN
Andon Health Co, Ltd.
Cardiovascular · 164d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K111826 · DXN
Andon Health Co, Ltd.
Cardiovascular · 164d
Cleared Dec 07, 2011
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 40d
Cleared Dec 06, 2011
NOVAPORT ONE VASCULAR ACCESS CANNULA
K112565 · DWF
Novalung GmbH
Cardiovascular · 95d