650 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·CentriMag Circulatory Support System
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·AGENT Paclitaxel-Coated Balloon Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·DiamondTemp Ablation System
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Pipeline Vantage Embolization Device with Shield Technology
Sensor, Glucose, Implanted, Non-Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MemoryGel Enhance Silicone Breast Implants
Implantable Pulse Generator
FDA Pre-Market Approval
FDA Class 3
·OPTIMIZER Smart System
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·INGEVITY+
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MULTI-LINK 8, MULTI-LINK 8 SV AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS)
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VISION RAPID EXCHANGE (RX) & MINI VISION RX MULTI-LINK FAMILY OF CORONARY STENT SYSTEM (CSS)
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Flow Re-Direction Endoluminal Device (FRED®) System
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RHA® Redensity, RHA® Redensity Mepi
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·CAPSURE SP NOVUS LEAD MODEL 5594
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM II, MODEL 3058 NEUROSTIMULATOR
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MemoryGel Breast Implants