Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Plexa ProMRI S DX ICD Leads

Sterile Microwave Ablation Probe

FDA registration

HYGEA MEDICAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

Sterile Co-Ablation Probe

FDA registration

HYGEA MEDICAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

Spine Needle (16 Gauge)

FDA UDI

ELLIQUENCE, LLC·00846338008017·

Spine Needle (18 Gauge)

FDA UDI

ELLIQUENCE, LLC·00846338000776·

R-Prime Elastic Traction System

FDA registration

BEIJING ROSSUMROBOT TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

R-Ronny Surgical Robotic Arm RR-02, RR-02-B

FDA registration

BEIJING ROSSUMROBOT TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

DEX Wrist Short

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Mediroyal Nordic AB·12 devices

DEX Wrist Long

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Mediroyal Nordic AB·12 devices

DEX Wrist Mid

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Mediroyal Nordic AB·12 devices

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278560049·Software Pristina 8.1 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278009289·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682145862·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682142373·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278711229·UDI Software Pristina

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682143516·

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00840682146845·Software Pristina Infinity

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278655141·Software Pristina 8.2 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278795724·Software Pristina 8.3 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278716026·UDI Software Pristina ME 9.1