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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES

Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

FDA classification
FDA Class 3 ·Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

Gases Used Within Eye To Place Pressure On Detached Retina

FDA classification
FDA Class 3 ·Gases Used Within Eye To Place Pressure On Detached Retina

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

FDA classification
FDA Class 3 ·Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA classification
FDA Class 3 ·Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

FDA classification
FDA Class 3 ·Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA classification
FDA Class 3 ·Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA classification
FDA Class 3 ·Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA classification
FDA Class 3 ·Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Permanent Defibrillator Electrodes

FDA classification
FDA Class 3 ·Permanent Defibrillator Electrodes

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA classification
FDA Class 3 ·Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents