Dispositivos

Nombre Clasificación Fabricante Nivel de riesgo País Fuente
EndoBarrier Gastrointestinal Liner System Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
IntelePACS software versions from 4.5.1 to 4.11.1. Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
IntelePACS(Image management system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Sapheon (Covidien) VenaSeal Closure System Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Tavo ophthalmic Table Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
KARMA Corneal Inlay Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy treatment planning system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Hemodialysis Monitor Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/Kits Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
EndoBarrier Gastrointestinal Liner with Delivery System Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
IMRIS Operating Room table (ORT300) General and Plastic Surgery Devices Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
INTELEPACS Version 3.8.1 and up (Radiology picture archiving and communication system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
MGuard Prime Coronary Stent System Embolic Protective Stent (EPS) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RaySearch RayStation, version 4.0.3 (Radiation therapy treatment planning system) Radiology Devices Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
INTELEVIEWER Versions 3.8.1 P355 and up (radiology picture archiving and communication system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation 3.5 and 4.0 (Radiation therapy treatment planning system) Radiology Devices Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation software versions 2.5, 3.0, 3.5, and 4.0 (radiation therapy treatment planning system) Radiology Devices Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
SuperElastic NiTi Archwires (intended to provide force to the teeth to effect movement in order to alter their position) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neurosurgical procedures for accurate positioning of mircoelectrodes, stimulating electrodes or other instruments in the brain or nervous system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation 3.0, 3.5, or 4.0 (Radiation therapy treatment planning system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RaySearch RayStation 3.0 and 3.5 (software versions 3.0.0.251, 3.5.0.16, 3.5.1.6) (Radiation treatment planning and analysis software) Date Manufactured: 15/02/2013 Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
PYRENEES Constrained plate 2 Level 36mm Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RaySearch RayStation 3.0 (Radiation treatment planning and analysis software) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
ORT100 Neurosurgical Table (for Intra-operative MRI Suites) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Various mass spectrometers - Quattro micro, ACQUITY TQD, Quattro Premier XE, Xevo TQ; In vitro diagnostic medical devices (IVD's) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia