1,739 results
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE -WIRE)
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Siello S and Solia S, EFH-6F-W and DH IS-1/DF4
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENDOTAK RELIANCE EZ IS-1 AND 4-SITE EZ QUADRIPOLAR ACTIVE FIXATION LEADS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTAK(R) PRX II/III AICD SYSTEM AND IS-1/DF-1 LEADS
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval Sutureless Heart Valve
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·PERCEVAL SUTURELESS HEART VALVE
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval S Sutureless Heart Valve; Perceval Plus Sutureless Heart Valve
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·Carbomedics Prosthetic Heart Valve (CPHV)
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·PERCEVAL PLUS SUTURELESS HEART VALVE