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

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

FDA Pre-Market Approval

Calcivis Imaging System

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart, OPTIMIZER Smart Mini

FDA Pre-Market Approval

CALCIVIS Imaging System

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 (2-Lead configuration)

FDA Pre-Market Approval

CALCIVIS Imaging 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 System

CS 9300C

FDA UDI

CARESTREAM HEALTH, INC.·60889975210964·CS 9300C 230V R

Omni

FDA UDI

GE MEDICAL SYSTEMS, INC.·00195278454218·OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY

CS 9300C

FDA UDI

CARESTREAM HEALTH, INC.·60889975210988·CS 9300C 230V

CS 9300C

FDA UDI

CARESTREAM HEALTH, INC.·60889975319698·CS 9300C 230V

Discovery

FDA UDI

GE MEDICAL SYSTEMS, INC.·00840682125703·

Discovery

FDA UDI

GE MEDICAL SYSTEMS, INC.·00840682146166·