123 results · 28ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System and HFX iQ System

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof Single Piece Intraocular Lenses

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF IQ RESTOR IOLS +3.0 D & +4.0 D ADD POWERS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System

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

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF IQ SINGLE-PIECE IOL WITH THE ACRYSERT C DELIVERY SYSTME

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof® IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Acrysof IQ Aspheric UV absorbing IOL with the UltraSert Pre-Loaded Delivery System