13 results · 12ms · Sources: EU EUDAMED, US FDA

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Prosthesis, Testicle

FDA classification
FDA Class 3 ·Prosthesis, Testicle

Antibody To Htlv-1, Elisa

FDA classification
FDA Class 3 ·Antibody To Htlv-1, Elisa

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification
FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Cranial Electrotherapy Stimulator To Treat Depression

FDA classification
FDA Class 3 ·Cranial Electrotherapy Stimulator To Treat Depression

Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

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

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

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

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

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

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

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

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