16 results · 19ms · Sources: EU EUDAMED, US FDA

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM Septal Occluder (GSO)

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE® CARDIOFORM Septal Occluder (GSO)

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER SEPTAL OCCLUDER DEVICE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Septal Occluder (ASO/ASD)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG)

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM