2,365 results · 19ms · Sources: EU EUDAMED, US FDA

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL AND PROPEL MINI SINUS IMPLANTS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS TORIC CALCULATOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·MENICON SF-P (MELAFOCON A) CONTACT LENS

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity™ Deep Brain Stimulation (DBS)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim™ Spinal Cord Simulation Implantable Pulse Generator (IPG)

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim™ Dorsal Root Ganglion (DRG) IPG

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval
FDA Class 3 ·UROVYSION BLADDER CANCER KIT

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Minerva Endometrial Ablation System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY PULSE GENERATORS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System with SmartGuard

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim SCS IPG

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity DBS IPG

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·iPro2 System