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

acra regulatory services pty ltd - 43467 - connector, mouthpiece, reusable - a disposable turbine and mouthpiece to be used with a device to test a patient?s lung function (reusable with single patient)

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

acra regulatory services pty ltd - 34831 - adhesive tape, general-purpose, hypoallergenic - adhesive tape pad is intended for use with radiation counting device sensor on clean, dry, intact skin. the sensor side adhesive is not intended for skin contact.

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

acra regulatory services pty ltd - 38332 - scintillation-counter radiation survey meter - radiation counting device is intended to dynamically indicate the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medical procedures and is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system, which is required for a nuclear medical procedure.

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

acra regulatory services pty ltd - 36888 - patient data recorder, long-term, sphygmomanometer - 24-hour blood pressure monitoring system intended to be used for automatic non-invasive measurement of freely moving patients? arterial pressure and heart rate under ambulatory and stationary conditions within long periods of time (from 24 hours to several days) with a view to diagnose patients? cardiovascular system condition.

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

acra regulatory services pty ltd -

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

acra regulatory services pty ltd - 58943 - ambulation exoskeleton, clinical - battery powered bionic wearable robot / exoskeleton system with smartassist software intended to be used ? by people with lower-extremity paralysis or weakness to get them standing up or walking; ? as gait training device to improve walking function and independence in patients with a neurological or muscular injury, illness, or weakness; ? to help facilitate the restoration or improvement of ambulation for patient; ? to manipulate the legs of a patient and move them through the normal walking gait, from the sit-to-stand position and from standing back to sitting ? by multiple patients over the duration of its life

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

acra regulatory services pty ltd - 38729 - electrocardiographic long-term ambulatory recorder, telemetric - the sirona holter/event recorder is a portable, battery-operated long-term telemetric ambulatory ecg recorder used by trained technicians to collect ecg data from patients in a clinical, point-of-care or outpatient setting.

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

acra regulatory services pty ltd -

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

acra regulatory services pty ltd - 61671 - orthopaedic bone washer, sterile - screw washer intended to be used with bone screws to improve fixation. washers are intended for single use only.

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

acra regulatory services pty ltd - 56642 - orthopaedic bone screw, non-biodegradable, non-sterile - trauma screw designed to apply compression and fixation between two adjacent segments of cortical and/or cancellous bone and intended to be for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. screws are intended for single use only.