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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI, ICD, DF-1 ICD, S DR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD, VR ICD; Visia AF M

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENROUTE® Transcarotid Stent System

Mitral Valve Repair Devices

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

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·XACT CAROTID STENT SYSTEM

Mitral Valve Repair Devices

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

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK & ACCULINK CAROTID STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Precise Nitinol Stent Systems

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·XACT CAROTID STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENROUTE Transcarotid Stent System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·CORDIS PRECISE NITINOL STENT SYSTEMS

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM

Mitral Valve Repair Devices

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

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK CAROTID STENT 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

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Carotid WALLSTENT™ Monorail Endoprosthesis 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)

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK CARTOID STENT SYSTEM