一 般 资 料

• 甚 麽 是 医 疗 仪 器 ？
• 已 分 级 的 医 疗 仪 器 例 子

专题

• 隆 胸
• 中 央 静 脉 导 管
• 隐 形 眼 镜
• 药 物 释 放 型 冠 状 动 脉 支 架
• 病 人 升 降 架
• 家 用 血 糖 机
• 可 多 次 使 用 的 内 窥 镜 / 腹 腔 镜 手 术 工 具 及 配 件
• 血 压 计
• 透 皮 神 经 电 刺 激 器
• 氧 气 浓 缩 机
• 阻 塞 性 睡 眠 窒 息 症 与 连 续 正 气 压 呼 吸 机

给医护专业人员的信

• 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
• Safety alert on Roche ACCU-CHEK FlexLink Plus Infusion Sets
• TGA issued alert on the use of Portable Blood Glucose (Posted on 24 Nov 2010)

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