1,547 results · 19ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS Opt

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS 3-Piece Acrylic Monofocal

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·TECNIS 3-Piece Multifocal

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Septal Occluder and Amplatzer Cribriform Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Muscular VSD Occluder

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Duct Occluder, Amplatzer Duct Occluder II

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer PFO Occluder

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Terminal Pin Weld Process Monitoring Plan

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF(R) IQ TORIC INTRAOCULAR LENS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·MODEL 6725 IS-1 PIN PLUG

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL CONCERT (PIN) Cochlear Implant

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ LEAD END PIN CAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACCESSORY-UPSIZING SLEEVE/LEAD END PIN CAP

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof® IQ ReSTOR® Intraocular Lenses

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof® IQ ReSTOR® Intraocular Lenses

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM