Devices

Name Classification Manufacturer Risk Class Country Source
Siemens e.cam Systems (Nuclear medicine gamma camera) Radiology Devices Siemens Healthcare Pty Ltd Australia
Artis Q and Q.zen Floorstand and ArtisQ and Q.zen Biplane Floorstand systems with SW version VD10E Siemens Healthcare Pty Ltd Australia
Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) Siemens Healthcare Pty Ltd Australia
ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelines Siemens Healthcare Pty Ltd Australia
ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B, VC30C, or VC31A Siemens Healthcare Pty Ltd Australia
Back Table Cover supplied in a limited range of Operating Room Packs Plus Medical Pty Ltd Australia
Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE Series Software versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits Medical Vision Aust Cardiology & Thoracic Pty Ltd Australia
Clements Suction Regulators BMDi TUTA Healthcare Pty Ltd Australia
Extension Set(extension tubing for blood transfusion systems and standard intravenous administration sets) BMDi TUTA Healthcare Pty Ltd Australia
CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD). MiniMed Paradigm insulin infusion pumps, MiniMed NGP Pumps, MiniMed Guardian Monitor REAL-Time and CONTOUR NEXT test strips. Bayer Australia Ltd Australia
REFRESH NIGHT TIME and Ircal Eye Ointments Allergan Australia Pty Ltd Australia
CA1:1L EVO 15 (Contrangle used in dentistry) William Green Pty Ltd Australia
MetaVision ICU version 6.0x - 6.9x IMDsoft Australia
iMDsoft MetaVision ICU (MV-ICU), Version 5.47.4622(graphical patient information system used for data collection, management, and storage) IMDsoft Australia
MetaVision ICU (MV-ICU) Version 5.47 IMDsoft Australia
EIZO Medical Monitors Arcadia Corporation Pty Ltd EIZO Oceania Australia
ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD) Haemokinesis Pty Ltd Australia
ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD). Haemokinesis Pty Ltd Australia
ALBAclone Anti-Leb, (LEB2) 1 x 5mL(Immunoglobulins capable of binding to specific red blood cell antigens and intended to be used in immunohaematological testing to provide information about red blood cell antigen phenotypes.) Haemokinesis Pty Ltd Australia
Neoss Guide – Drill-Hubs I to V included in Neoss Neoss Australia Pty Ltd Australia
Active Knee Total Knee Replacement System Allegra Orthopaedics Limited Australia
PF6 Tube Assembly (a component of the Peripheral Vascular Infusion/Aspiration Catheter or “PAD” catheter) Allegra Orthopaedics Limited Australia
True Cut Oscillating Blade, 0.9mm x 80mm x 12mm, single use device (used to cut skeletal bone and tissue) Allegra Orthopaedics Limited Australia
Suction Adapter Type A (Gauge) Xcel Medical Solutions Pty Ltd Australia
Shuttle Discovery Seat (designed for children aged between six months and four years who have a physical disability) Medifab Ltd Australia