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

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

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

FDA Pre-Market Approval
FDA Class 3 ·4Kscore Test

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

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

FDA Pre-Market Approval
FDA Class 3 ·The 4Kscore Test

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

FDA Pre-Market Approval
FDA Class 3 ·4Kscore Test

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

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA Pre-Market Approval
FDA Class 3 ·Et Control

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

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

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Liberta RC Deep Brain Stimulation Implantable Pulse Generator

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Eterna Spinal Cord Stimulation Implantable Pulse Generator

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

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/Claria Quad CRT-D/ Brava Quad CRT-D/ Compia MRI Quad CRT-D/ Viva Qua

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P and Solara Bipolar/Qu