General Information

• What is a Medical Device?
• Classified Examples of Medical Devices

Selected Documents

• Breast Augmentation
• Central Venous Catheter (CVC)
• Contact Lens
• Drug-eluting Coronary Stent
• Patient Hoist
• Home-use Blood Glucose Meter
• Reusable Endoscopic / Laparoscopic instruments and accessories
• Blood Pressure Monitor
• TENS Machine
• Oxygen Concentrator
• Obstructive Sleep Apnea and CPAP Respirator

Letters to Healthcare Professionals

• Discontinuation of "Macrolane" for use in breast augmentation (Posted on 24 Apr 2012)
• Risk of life-threatening embolism related to the use of air- or gas-pressurised spray devices for application of sprayable fibrin sealants (Posted on 12 Apr 2012)
• Safety concerns over metal-on-metal total and hip resurfacing hip replacement systems (Posted on 5 April 2012)
• Risk of non-invasive ventilation devices being used as life-supporting ventilators (Posted on 9 Feb 2012)
• Possible association between breast implants and Anaplastic Large Cell Lymphoma (ALCL) of the breast (Posted on 14 Dec 2011)
• FDA Issued Safety Communication on Preventing Surgical Fires (Posted on 17 Oct 2011)
• Voluntary Recall Notification for Nucleus CI500 cochlear implant range (Posted on 14 Sept 2011)
• FDA Updates on Precautions with Audible Alarms on Ventilators
• TGA issued safety information on endoscopes repairs (Posted on 26Aug 2011)
• Health Canada Issued Important Safety Information on Central Vascular Access Devices (Posted on 25 Aug 2011)
• Recall of Bayer's Contour and Contour TS Glucose Test Strips
• Recall of Two Intrauterine Contraceptive Devices(IUCDs) Mona Lisa CuT 380A and NT Cu380
• Recall of Pentron Clinical 37% Phosphoric Acid Etching Gel (Posted on 27 Jun 2011)
• Recall of Braunoderm Disinfectant Solution (Posted on 24 May 2011)
• Medical Device Alert: Boston Scientific Device Stolen - Risk of Infection (Posted on 5 May 2011)
• Alert on voluntary recall and corrective action by Defibtech on semi-automatic external defibrillators (Posted on 5 May 2011)
• FDA Updates on Serious Complications Associated with Negative Pressure Wound Therapy Systems (Posted on 2 March 2011)
• Safety alert on Roche ACCU-CHEK FlexLink Plus Infusion Sets (Posted on 2 March 2011)
• TGA issued alert on the use of Portable Blood Glucose (Posted on 24 Nov 2010)

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