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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)

PRO-DEX Surgical Driver

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pro-Dex, Inc.·1 device

PRO-DEX Surgical Driver

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pro-Dex, Inc.·1 device

PRO-DEX Surgical Driver

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pro-Dex, Inc.·1 device

PRO-DEX Surgical Driver

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Pro-Dex, Inc.·1 device

SINMED POSITIONING DEVICES

FDA 510(k)

FDA Class 2 ·Radiology