240 results · 17ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GEM, ENTRUST, MARQUIS, MAXIMO, INTRINSIC AND VIRTUSO FAMILIES OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip™ NTR/XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip G4 Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip and MitraClip NT Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip System (NT)

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip™ G4 Clip Delivery System; MitraClip™ NTR Clip Delivery System; MitraClip™ XTR Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip System (NTR and XTR)

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NTR, XTR and G4 Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip G4 System