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
6745–6768 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 05, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
K063313 · NTE
Boston Scientific Corp
Cardiovascular · 33d
Cleared Dec 04, 2006
MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
K063419 · MWI
Welch Allyn Protocol, Inc.
Cardiovascular · 21d
Cleared Dec 04, 2006
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
K062769 · DXO
Radi Medical Systems AB
Cardiovascular · 80d
Cleared Dec 01, 2006
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
K063012 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 60d
Cleared Nov 30, 2006
MAPMATE
K063277 · DQK
Ep Medsystems, Inc.
Cardiovascular · 30d
Cleared Nov 30, 2006
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
K062340 · LYK
Cardio-Optics, Inc.
Cardiovascular · 112d
Cleared Nov 30, 2006
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140,...
K062271 · MHX
Philips Medical Systems
Cardiovascular · 115d
Cleared Nov 30, 2006
VASOPRESS DVT SYSTEM, MODEL VP500D
K061814 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 156d
Cleared Nov 22, 2006
MICRO-INFUSION SYSTEM
K062507 · QEY
Ekos Corp.
Cardiovascular · 86d
Cleared Nov 22, 2006
HEARTSTART MRX MONITOR/DEFIBRILLATOR
K062233 · MKJ
Philips Medical Systems North...
Cardiovascular · 112d
Cleared Nov 22, 2006
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120
K061951 · QEZ
Possis Medical, Inc.
Cardiovascular · 135d
Cleared Nov 21, 2006
TELEMEDICINE SYSTEM MODEL VMS-01
K062662 · DRG
Medic4all (Israel) , Ltd.
Cardiovascular · 75d
Cleared Nov 20, 2006
INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80...
K063315 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 18d
Cleared Nov 17, 2006
ASAHI PRECIOUS GUIDE CATHETER
K061601 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 162d
Cleared Nov 15, 2006
ELI 350 ELECTROCARDIOGRAPH
K062677 · DPS
Mortara Instrument, Inc.
Cardiovascular · 68d
Cleared Nov 14, 2006
ATB ADVANCED PTA DILATATION CATHETER
K063252 · DQY
Cook, Inc.
Cardiovascular · 18d
Cleared Nov 14, 2006
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
K063222 · QYX
Cardionet, Inc.
Cardiovascular · 21d
Cleared Nov 14, 2006
SPIDERFX EMBOLIC PROTECTION DEVICE
K063204 · NTE
Ev3, Inc.
Cardiovascular · 22d
Cleared Nov 09, 2006
SMITHWICK CAROTID SHUNT
K062474 · DXC
Mcpherson Enterprises, Inc.
Cardiovascular · 77d
Cleared Nov 09, 2006
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
K062186 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 101d
Cleared Nov 09, 2006
GORE PROPATEN VASCULAR GRAFT
K062161 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 104d
Cleared Nov 08, 2006
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)
K062127 · DRG
Medic4all (Israel) , Ltd.
Cardiovascular · 106d
Cleared Nov 08, 2006
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
K061935 · DXN
Sensacare , Ltd.
Cardiovascular · 121d
Cleared Nov 08, 2006
HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0
K061905 · DQK
Medcon , Ltd.
Cardiovascular · 126d