12 results · 18ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO(R) RELEASE III SOFTWARE 5OO SERIES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure™ Preloaded IOL System / Model B1PC (Clear

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PreVue Pre-Loaded System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Preloaded System

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·BETA-CATH(TM) SYSTEM

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·Straumann Emdogain

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Preloaded IOL System, IPure™ Preloaded IOL System