Devices

Name Classification Manufacturer Risk Class Country Source
Multiple Polishing Products containing Optrapol (a dental polishing system) Ivoclar Vivadent Pty Ltd Australia
Zenostar MT Color and Zenostar MT Color Impulse products Ivoclar Vivadent Pty Ltd Australia
Helioseal Clear, 1.25g syringes Ivoclar Vivadent Pty Ltd Australia
Sureclip and Sureclip Plus Haemostasis Clips (Gastrointestinal endotherapy clip applier) Hemoclip 90 degree/5mm/12mm(max) rotatable/relocatable (x10/box) Hemoclip 90 degree/8mm/17mm(max) rotatable/relocatable (x10/box) CK Surgitech Pty Ltd Australia
ME DPHC 0001 deltastream HC, 230V (Cardiopulmonary bypass system heating/cooling unit) Lovell Surgical Supplies International Pty Ltd Australia
Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter Monitoring System 500 Lovell Surgical Supplies International Pty Ltd Australia
Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits) Conceiveplease Pty Ltd Australia
Pentax ED-3490TK Video Duodenoscope Hoya Lens Australia Pty Ltd Australia
Mums The One One Step hCG Urine Pregnancy Test Mums The One Australia
Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms) Stryker South Pacific Australia
Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit Ellex Medical Pty Ltd Australia
Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT) Ellex Medical Pty Ltd Australia
Mizuho General Purpose Operating Table Hipac Healthcare Pty Ltd Australia
Papoose Infant Spine Immobilisers Ossur Australia - OA & Injury Solutions Pty Ltd Australia
Danis Procedure Pack and Danis Procedure Pack - Basic Endotherapeutics Pty Ltd Australia
SerenoCem Granules BCG050 (Orthopaedic bone cement) Endotherapeutics Pty Ltd Australia
Xhibit Central Station, software version 1.1.5 Ecomed Pty Ltd Australia
Xhibit Central Station (patient monitoring system) Cardiovascular Devices Ecomed Pty Ltd Australia
Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-Clip Alphabond Dental Pty Ltd Australia
Resus-EZY Air Cushion Mask Schell Medical Corporation Pty Ltd Australia
Resus-EZY Manual Resuscitator (single-use pulmonary resuscitator) Schell Medical Corporation Pty Ltd Australia
Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tube feeding) Merck Pty Ltd Australia
Volker LTC bed (with lateral release button for the side rails) Iona Medical Products Australia
REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes) Rex Bionics Australia Pty Australia
Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D) LivaNova Australia Pty Ltd Australia