10,000 results · 50ms · Sources: EU EUDAMED, US FDA

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·Rotablator™and ROTAPRO™ Rotational Atherectomy System, RotaWire™ Guidewire and wireClip™ Torquer, ROTAWIRE™ Drive Guidew

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·LEAD ASSEMBLY

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Cobas HBV

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Assurity MRI and Endurity MRI

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·DURALOC OPTION CERAMIC HIP SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT (MODEL 105)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·E-LUMINEXX VASCULAR STENT

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER MULTI-FENESTRATED SEPTAL OCCULDER (CRIBRIFORM)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BIOLON

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, RELIA IPG

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS- (MODELS 305. 310)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SENSE BIPOLAR LEAD 4074, CAPSURE SENSE BIPOLAR LEAD 4574

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·CARDIOGENESIS TMR SYSTEM