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

Electrical Impedance Spectrometer

FDA classification
FDA Class 3 ·Electrical Impedance Spectrometer

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA classification
FDA Class 3 ·Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Stimulator, Electrical, Implanted, For Essential Tremor

FDA classification
FDA Class 3 ·Stimulator, Electrical, Implanted, For Essential Tremor

Ablation Catheter, Renal Denervation

FDA classification
FDA Class 3 ·Ablation Catheter, Renal Denervation

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA classification
FDA Class 3 ·Continuous Glucose Monitor, Implanted, Adjunctive Use

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA classification
FDA Class 3 ·Stimulator, Autonomic Nerve, Implanted (Depression)

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA classification
FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Implantable Pulse Generator

FDA classification
FDA Class 3 ·Implantable Pulse Generator

Bone Grafting Material, Dental, With Biologic Component

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

Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

Extended Depth Of Focus Intraocular Lens

FDA classification
FDA Class 3 ·Extended Depth Of Focus Intraocular Lens

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Acute Coronary Syndrome Event Detector

FDA classification
FDA Class 3 ·Acute Coronary Syndrome Event Detector

Iliac Covered Stent, Arterial

FDA classification
FDA Class 3 ·Iliac Covered Stent, Arterial

Tympanostomy Tube Delivery Product With Drug

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

Kit, Rna Detection, Human Papillomavirus

FDA classification
FDA Class 3 ·Kit, Rna Detection, Human Papillomavirus

Agent, Occluding, Vascular, Permanent

FDA classification
FDA Class 3 ·Agent, Occluding, Vascular, Permanent

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

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

Tissue Adhesive For Internal Use

FDA classification
FDA Class 3 ·Tissue Adhesive For Internal Use

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA classification
FDA Class 3 ·Prostrate Cancer Genes Nucleic Acid Amplification Test System