1,635 results · 18ms · Sources: EU EUDAMED, US FDA

Mandibular Condyle Prosthesis

FDA classification
FDA Class 3 ·Mandibular Condyle Prosthesis

Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight

FDA classification
FDA Class 3 ·Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight

Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

FDA classification
FDA Class 3 ·Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

Adhesive, Denture, Karaya With Sodium Borate

FDA classification
FDA Class 3 ·Adhesive, Denture, Karaya With Sodium Borate

Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer

FDA classification
FDA Class 3 ·Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer

Kit, Test, In Vitro Periodontal

FDA classification
FDA Class 3 ·Kit, Test, In Vitro Periodontal

Bone Grafting Material, Dental, With Biologic Component

FDA classification
FDA Class 3 ·Bone Grafting Material, Dental, With Biologic Component

Solution, Removal, Carries

FDA classification
FDA Class 3 ·Solution, Removal, Carries

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification
FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Sensor, Glucose, Invasive

FDA classification
FDA Class 3 ·Sensor, Glucose, Invasive

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect system

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

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA classification
FDA Class 3 ·Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Automated Insulin Dosing Device System, Single Hormonal Control

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

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Balloon System