2,316 results · 19ms · Sources: EU EUDAMED, US FDA

Reherniation Reduction Device

FDA classification
FDA Class 3 ·Reherniation Reduction Device

Computer-Assisted Personalized Sedation System

FDA classification
FDA Class 3 ·Computer-Assisted Personalized Sedation System

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

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

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA classification
FDA Class 3 ·Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification
FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA classification
FDA Class 3 ·Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

Test, Urea Adult And Pediatric (Breath),

FDA classification
FDA Class 3 ·Test, Urea Adult And Pediatric (Breath),

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification
FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Barrier, Adhesion, Cardiovascular

FDA classification
FDA Class 3 ·Barrier, Adhesion, Cardiovascular

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

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

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA classification
FDA Class 3 ·Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA classification
FDA Class 3 ·Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA classification
FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Immunohistochemistry Antibody Assay, C-Kit

FDA classification
FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

FDA classification
FDA Class 3 ·Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

FDA classification
FDA Class 3 ·Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Aortic Stent

FDA classification
FDA Class 3 ·Aortic Stent

Intracranial Coil-Assist Stent

FDA classification
FDA Class 3 ·Intracranial Coil-Assist Stent

Whole Blood Pre-Treatment T-Cell Enrichment Reagent

FDA classification
FDA Class 3 ·Whole Blood Pre-Treatment T-Cell Enrichment Reagent

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA classification
FDA Class 3 ·System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection