Devices

Name Classification Manufacturer Risk Class Country Source
C-Series LiftsPrism Medical/Waverly Glen FSN-0016A Rehab Assist Pty Ltd Australia
C-series carry bars (used with C300, C450 Manual, C625 ceiling lifts/hoists) Rehab Assist Pty Ltd Australia
Prism Medical P300 and C300 Lifts Rehab Assist Pty Ltd Australia
Vaios Total Shoulder Replacement System Orthotech Pty Ltd Australia
ClaveGuard Diathermy Pencil ClaveGuard Pty Ltd Australia
OLS-500 & OLS-700 surgical lightsAll OLS500/OLS700 lights manufactured and installed since January 2015 may be affected. ClaveGuard Pty Ltd Australia
SwishTapered Implant 4.1mmD x12mmL SBM Dual Blast; 4.8mmD Platform Implant Direct Oceania Pty Ltd Australia
Spectra System/Legacy Guided Surgery Handle Kit Inserts Implant Direct Oceania Pty Ltd Australia
DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender Implant Direct Oceania Pty Ltd Australia
ECG Electrode Atris Pty Ltd Australia
Karma Wheelchairs Item Name: Flexx(KM-8022)18*18 Independent Home Care & Surgical Supplies Pty Ltd Australia
Dialysis Treatment Therapy Pack 105 Fresenius Medical Care Packs Australia Australia
Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis Fistula Pack 5FME Fresenius Medical Care Packs Australia Australia
MediRedi Fistula Packs Melbourne Health Unit Fistula Pack, Melbourne Health Unit Fistula Pack, A.V. Fistula Set for Haemodialysis House With No Steps Hunter Valley Region Australia
MediRedi A.V. Fistula Pack (contains the Terumo AVF Set for Haemodialysis) House With No Steps Hunter Valley Region Australia
STALORAL and PHOSTALSTALORAL (range of sublingual solutions of allergen extracts for allergen immunotherapy) Stallergenes Australia Pty Ltd Australia
Hypochlorite 1% Solution & Hypochlor 1% Solution Dentalife Australia Pty Ltd Australia
Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback device Device Consulting Pty Ltd Australia
miraDry System (used for the treatment of primary axillary hyperhidrosis) Device Consulting Pty Ltd Australia
AMBU Ultraseal II Anaesthetic Mask AMBU Australia Pty Ltd Australia
Ambu AuraGain Single Use Laryngeal Mask – Sterile AMBU Australia Pty Ltd Australia
One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD) Murray International Trading Pty Ltd Australia
Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILE General Hospital and Personal Use Devices Fresenius Kabi Australia Pty Ltd Australia
Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory Fresenius Kabi Australia Pty Ltd Australia
Curlin 6000 and Painsmart IOD Ambulatory Infusion Pumps Fresenius Kabi Australia Pty Ltd Australia