20 results · 7ms · Sources: EU EUDAMED, US FDA

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Absorbable Collagen Hemostatic Agent With Thrombin

FDA classification
FDA Class 3 ·Absorbable Collagen Hemostatic Agent With Thrombin

Tympanostomy Tube Delivery Product With Drug

FDA classification
FDA Class 3 ·Tympanostomy Tube Delivery Product With Drug

Adhesive, Denture, Karaya With Sodium Borate

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

Bone Grafting Material, Dental, With Biologic Component

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

Caries Detection Product With Drug Or Biologic

FDA classification
FDA Class 3 ·Caries Detection Product With Drug Or Biologic

Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

FDA classification
FDA Class 3 ·Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

FDA classification
FDA Class 3 ·Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification
FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA classification
FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA classification
FDA Class 3 ·Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification
FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA classification
FDA Class 3 ·Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

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

Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

FDA classification
FDA Class 3 ·Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

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

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA classification
FDA Class 3 ·Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA classification
FDA Class 3 ·Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA classification
FDA Class 3 ·Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

FDA classification
FDA Class 3 ·Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

FDA classification
FDA Class 3 ·Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator