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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MAXIMO VR MODELS 7232B AND 7232 IMPLANTABLE CARDIAC DEFIBRILLATORS (ICDS)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·(LGW, QRB) - Master Restore Spinal Cord Stimulation Systems

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

Phakic Toric Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Visian Toric ICL (IMPLANTABLE COLLAMER LENS)

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER® Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER® Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini IPG

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·Optimizer Smart System and Optimizer Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIhome Remote Patient Monitoring System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart IPG

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·Optimizer Smart System (IPG)

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart and Smart Mini

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini (OSM) system

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·GUARDIO/VESTA Charger firmware