614 results · 18ms · Sources: EU EUDAMED, US FDA

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MHY

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire UAS High AHI/High BMI

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire II Upper Airway Stimulator

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

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

FDA Pre-Market Approval
FDA Class 3 ·INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 7232

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Upper Airway Stimulation System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·All Flex 4-Socket Hi-POT/Pulse Test System

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval
FDA Class 3 ·Ki-67 IHC pharmDx

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval
FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology