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
4153–4176 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 01, 2013
PETITE BASIC SYSTEM 701 ELT
K131420 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 169d
Cleared Nov 01, 2013
SILK ROAD ACCESS CATHETER
K130649 · DQY
Silk Road Medical, Inc.
Cardiovascular · 235d
Cleared Oct 31, 2013
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING...
K132995 · DWF
Medtronic, Inc.
Cardiovascular · 37d
Cleared Oct 31, 2013
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · DTE
Medtronic, Inc.
Cardiovascular · 43d
Cleared Oct 31, 2013
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · PDU
Boston Scientific Corp
Cardiovascular · 127d
Cleared Oct 31, 2013
FIRMAP CATHETER
K130827 · MTD
Topera, Inc.
Cardiovascular · 219d
Cleared Oct 30, 2013
VENOUS HARDSHELL CARDIOTOMY RESERVOIR
K132166 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 110d
Cleared Oct 29, 2013
MYPATCH
K131190 · DSH
Dms-Service, LLC
Cardiovascular · 186d
Cleared Oct 28, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K132972 · DTN
Medtronic, Inc.
Cardiovascular · 35d
Cleared Oct 28, 2013
ITCLAMP 50
K132651 · DXC
Innovative Trauma Care, Inc.
Cardiovascular · 63d
Cleared Oct 28, 2013
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
K132083 · KRD
MicroVention, Inc.
Cardiovascular · 115d
Cleared Oct 28, 2013
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
K131446 · DQR
Integra LifeSciences Corporation
Cardiovascular · 161d
Cleared Oct 25, 2013
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K132020 · LIT
Cook, Inc.
Cardiovascular · 116d
Cleared Oct 25, 2013
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · QEY
Covidien
Cardiovascular · 207d
Cleared Oct 25, 2013
MEDUSA VASCULAR PLUG
K123696 · KRD
Endoshape, Inc.
Cardiovascular · 326d
Cleared Oct 24, 2013
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
K132556 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 71d
Cleared Oct 23, 2013
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K132627 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 62d
Cleared Oct 23, 2013
OPTUM TELEHEALTH APPLICATION
K130971 · DRG
Optumhealth Care Solutions, Inc.
Cardiovascular · 198d
Cleared Oct 22, 2013
OCCLUSION BALLOON CATHETER
K132990 · MJN
Boston Scientific Corp
Cardiovascular · 28d
Cleared Oct 22, 2013
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4...
K132673 · DQY
Medtronic, Inc.
Cardiovascular · 56d
Cleared Oct 18, 2013
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · KRA
Boston Scientific Corp
Cardiovascular · 29d
Cleared Oct 18, 2013
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K130684 · MKJ
Philips Medical Systems
Cardiovascular · 219d
Cleared Oct 17, 2013
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
K132430 · LIT
Boston Scientific Corp
Cardiovascular · 73d
Cleared Oct 17, 2013
INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
K131872 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 115d