Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

life healthcare pty ltd - 62650 - torso intraoperative positioner - a preformed reusable pad designed to be attached to an operating table for stabilizing a patient's chest to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - tetrabenazine - oral tablet - 25mg

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

merit medical australia pty ltd - 44714 - cover, ultrasonic probe, intraoperative - protective cover or sheath placed over guide. the sheath allows the use of the scout guide for body surface and intraoperative procedures, while helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the guide.the cover also provides a means for maintenance of a sterile field (sterile covers only).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

cochlear ltd - 64985 - cochlear implant intraoperative electrophysiological analysis software - the nucleus smartnav is the application software of the smartnav system. it communicates with and controls a compatible cochlear surgical processor so as to perform a range of intraoperative measurements during ci surgery, in order to provide feedback to the surgeon regarding electrode insertion, function and final positioning. nucleus smartnav is installed and runs on a compatible tablet computer and communicates wirelessly with the surgical processor the smartnav app is intended to provide intraoperative feedback and metrics to the surgeon during cochlear implant surgery. it is indicated for use during cochlear implant surgery for recording and analysing metrics related to the placement and function of the straight (lateral wall) or perimodiolar electrode arrays of compatible cochlear implants.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

cochlear ltd - 64984 - cochlear implant intraoperative electrophysiological transceiver - the cochlear surgical processor is the external, battery powered processing unit of the smartnav system. it facilitates a range of intraoperative measurements during ci surgery, in order to provide feedback to the surgeon regarding electrode insertion, function and final positioning. this processing unit communicates with the implant receiver through a sterile barrier, and also communicates with and is controlled by the smartnav system application software installed on a tablet computer. the cp1150s surgical processor is designed to be used by surgeons and clinical partners with the cochlear nucleus smartnav app for intraoperative surgical diagnostic information. indicated for use during cochlear implant surgery for recording and analysing metrics related to the placement and function of the straight (lateral wall) or perimodiolar electrode arrays of compatible cochlear implants.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

kls martin australia pty ltd - 64172 - orthognathic surgery intraoperative occlusal positioner - orthognathic surgery intraoperative occlusal positioner[64172 a custom-made (i.e., made to the specifications of a specific patient), synthetic polymer wafer intended to be placed between the occlusal surfaces of a patient?s teeth to maintain the desired position of the patient?s jaw during corrective jaw surgery (orthognathic surgery); it may additionally be used post-surgery as a reference of the corrected-jaw position. it is not intended for orthodontic/dental use. this is a single-use device.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

getz healthcare pty ltd - 44714 - cover, ultrasonic probe, intraoperative - the protective covers are used over imaging probes or instruments to provide a sterile field and minimize cross contamination during diagnostic imaging or surgical procedures, operating on the body surface, intra-cavity, and intraoperative procedures.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

innovative medcare technology pty ltd - 62650 - torso intraoperative positioner - a preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). it is typically used when the patient is in the prone or lateral position; components for attachment to the operating table (e.g., adaptors, straps) may be included. this is a reusable device.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

thermo fisher scientific australia pty ltd - 44714 - cover, ultrasonic probe, intraoperative - this is a medical device used over imaging probes or instruments to provide a sterile protection, and to minimize cross contamination during diagnostic imaging procedures used intraoperatively, e.g., on internal organs, during an ultrasound examination. this is a single-use device.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

metaoptima technology australia pty ltd - 18021 - dermatoscope - molescope? lite is a handheld magnifier intended for examining intact skin, nail and hair by laypersons and healthcare professionals. optionally, molescope? lite can be attached to a smartphone or tablet to capture digital images within the specifications of the mobile device. molescope? lite is not a diagnostic or a therapeutic device.