10,000 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DEFLUX INJECTABLE GEL
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·MOSAIC PORCINE BIOPROSTHESIS MODEL 305
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·AKREOS INTRAOCULAR LENS,MODEL AO60 and MI60L
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·VASCADE 6/7f VCS & VASCADE 5F VCS
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·iDESIGN Refractive Studio; STAR Excimer Laser System
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Cerene Cryotherapy Device
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Wave Writer Alpha Spinal Cord Stimulator (SCS) System, Spectra Wave Writer Spinal Cord Stimulator (SCS) System, Precis
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Pipeline Flex Embolization Device
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·STYLE UV40 POSTERIOR CHAMBER LENS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VISION & ML8 CORONARY STENT SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·INAMED SILICONE-FILLED BREAST IMPLANTS
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Therapy Ablation Catheter (including Bi-Directional Catheter) Therapy 4mm Thermistor Ablation Catheter
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM
Agent, Injectable, Embolic
FDA Pre-Market Approval
FDA Class 3
·Apollo Onyx Delivery Micro Catheter
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·DURATA FAMILY OF HIGH VOLTAGE LEADS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate 3 Left Ventricular Assist System