963 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·Essure System for Permanent Birth Control (Model ESS305)
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·PROGEL PLEURAL AIR LEAK SEALANT
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·SUPERA PERIPHERAL STENT SYSTEM (SUPERB)
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·SIENTRA SILICONE GEL BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MEMORYGEL BREAST IMPLANT
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·SCULPTRA
Stimulator, Low Electric Field, Tumor Treatment
FDA Pre-Market Approval
FDA Class 3
·NOVOCURE NOVOTTF-100A SYSTEM
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·OPEN PIVOT BI-LEAFLET HEART VALVE
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·XACT CAROTID STENT SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TALENT THORACIC STENT GRAFT SYSTEM
Barrier, Adhesion, Cardiovascular
FDA Pre-Market Approval
FDA Class 3
·REPEL-CV
Diagnostic Low Electric Field
FDA Pre-Market Approval
FDA Class 3
·MARGINPROBE SYSTEM
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Intraocular Pressure Lowering Implant
FDA Pre-Market Approval
FDA Class 3
·CYPASS SYSTEM
Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
FDA Pre-Market Approval
FDA Class 3
·ASCENSION MCP