147 results · 17ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER® Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·GUARDIO/VESTA charger

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER® Smart Mini

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMZER Smart Mini IPG Firmware

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

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·VESTA/GUARDIO Charger

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

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

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

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart, Smart Mini, and Lite Systems

Immunocytochemistry Assay, P16/Ki-67

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

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite

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

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini Implantable Pulse Generation (IPG)

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER SMART MINI, INTELIO Programmer, OPTIhome Remote Patient Monitoring System, Universal GUARDIO