Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 35615 - surgical staple, non-bioabsorbable - the endoscopic stapler reloads has applications in general, abdominal, gynaecologic, paediatric and thoracic surgery for resection, transection and creation of anastomoses. this is a single-use device. the device may also be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 59871 - endoscopic manual linear cutting stapler, single-use - the endoscopic stapler handle has applications in general, abdominal, gynaecological, paediatric and thoracic surgery for resection, transection and creation of anastamoses. this is a single-use device. the device may also be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 59016 - subcutaneous glucose sensor - the sensor is comprised of an applicator, sensor pod, and sensor wire. the sensor wire is made of silver and platinum with layers of membranes, one of which includes glucose oxidase. the applicator helps to insert the sensor wire inside the sensor pod under the skin. once inserted, the wire measures glucose levels in interstitial fluid for up to 10 days. the dexcom g6 continuous glucose monitoring system (dexcom g6 system or g6) is a glucose monitoring system indicated for persons with diabetes mellitus age 2 years and older where self-monitoring of blood glucose (smbg) is indicated. the dexcom g6 system is designed to replace fingerstick blood glucose (bg) testing for treatment decisions. interpretation of the dexcom g6 system results should be based on the glucose trends and several sequential readings over time. the dexcom g6 system also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. the dexcom g6 system is intended for use by patients at home and in healthcare facilities. the dexcom g6 cgm system is also designed to reliably and securely transmit glucose management data to digitally connected devices, including automated insulin dosing (aid) systems, and is intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 63386 - x-ray image interpretive software - the chest x-ray product, qxr analyses all chest radiographs that meets the inclusion criteria. qxr detects suspected abnormalities in the chest x-ray and localizes them and primarily provides clinically relevant tags. additionally, the software has the capability to provide position of the suspected abnormalities, if relevant. the results produced by qxr is intended to be used to support certified radiologists or other licensed medical practitioner for clinical decision making. it is a support tool to assist the clinician (radiologist) used with original radiographs to improve efficiency, accuracy and turnaround time and is not to be used as a source of medical advice or determine treatment plan or recommend a course of action for the patient.

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 57793 - public respirator, single-use - the device is a non-powered air-purifying respirator which can provide protection against particles including dust, smoke, fog and microbes.

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 35177 - mask, surgical, single use - the tenamyd/ tenami medical face masks are intended to be worn by the general public or healthcare personnel. the mask covers the user's nose and mouth to protect the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment. the mask is a disposable, single-use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 57812 - radiology dicom image processing application software - us2.v1 is a software platform that automatically processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, producing a full report with measurements of several key cardiac structural and functional parameters. the data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making based on dicom images produced by fda approved ultrasound devices. us2.v1 is indicated for use in adult patients. us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 44138 - ultrasonic lithotripsy system transducer, single-use - the coronary intravascular lithotripsy catheter consists of a standard percutaneous transluminal coronary angioplasty balloon catheter with integrated lithotripsy emitters. the application of lithotripsy mechanical pulse waves alters the structure of calcified vascular deposit (stenosis) prior to low pressure balloon dilation of the stenosis and facilitates the passage of blood and enhances placement of a stent. the catheter is intended to be used with a proprietary generator. the shockwave c2 coronary ivl system is indicated for lithotripsy-enhanced, lowpressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 62980 - balance-training tongue electrical stimulation system - the pons device is a non-implantable neurostimulator intended for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. pons is not intended to be used alone without an exercise program.

Australia - English - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 44138 - ultrasonic lithotripsy system transducer, single-use - the shockwave s4 peripheral ivl system is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries, in patients who are candidates for percutaneous therapy. not for use in the coronary, cerebral, aortic, or common iliac vasculature.