Sudáfrica - inglés - South African Health Products Regulatory Authority (SAHPRA)

sandoz south africa (pty) ltd - implant - see ingredients - each implant contains leuprorelin acetate equivalent to leuprorelin 5,0 mg

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

med-el implant systems australasia pty ltd - 30084 - partially-implantable middle ear implant system - the vorp 503 is the implanted part of the vibrant soundbridge system, surgically implanted into the temporal bone under the skin. it is designed to be used with a vibroplasty coupler, as decided by the surgeon, when attaching the fmt to a vibratory structure of the ear, or alone, when placing the fmt directly at the round window. when activated, the fmt vibrates in a controlled manner causing the structure of the middle ear to vibrate. these vibrations are interpreted by the patient as sound. the vibrant soundbridge vorp 503 implant kit contains one implant vorp 503 and other items. the vorp 503 is the implanted part of the vibrant soundbridge system. it is an active implant, which is implanted into the temporal bone under the skin during a surgical procedure. the vorp 503 is designed to be used with one of the vibroplasty couplers, as decided by the surgeon, when attaching the fmt to a vibratory structure of the ear, or alone, when placing the fmt directly at the round window. this treatment of hearing loss via vibratory stimulation in the middle ear is called vibroplasty. the vibrant soundbridge is indicated for use in patients who have mild to severe hearing impairment and cannot achieve success or adequate benefit from traditional therapy.

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

emergo asia pacific pty ltd t/a emergo australia - 33968 - screwdriver, surgical - a tool used for placement or removal of a screw in a dental implant. one end of the tool fits into the dental implant (or screw) and the other end of the tool is designed to fit into a chuck with a handle to allow the use of a power driver.

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

life healthcare pty ltd - 58084 - diaphysis prosthesis - composed of tial6v4 with silver anti-infective coating. a component of the mutars (modular universal tumor and revision) system. connects between the mutars diaphyseal implant and an extension piece or directly to a femoral stem. a connecting part for a diaphyseal implant to bridge diaphyseal bone defects of the femoral bone with a silver coating to prevent infection and colonisation of the implant. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis. the silver coated surface builds a long term prophylaxis against the colonisation of human pathogenic bacteria such as staphylococcus aureus and epidermis, exclusive enterobacteriae and should not be considered as acute treatment.

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

ge healthcare australia pty ltd - 60734 - non-implantable needle guide, reusable - this device is intended to be used as a reusable biopsy guide which the customer sterilizes before use. combination use with ultrasound probe to navigate needle direction and position

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

implant solutions pty ltd (trading as osteon medical) - 61642 - dental implant analog - analogues are used to simulate the position, direction, and connection of an implant and, consequently, to facilitate the manufacture of dental prostheses in the laboratory.

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

aimtek pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - the device comprises ? a patient movement sensor with attachment cradle. ? a guidance sensor arranged to dock with various standard reaming and acetabular cup placement devices. ? each sensor is a self-contained 3 axis solid state 3.6 volt battery powered device with bluetooth connectivity providing constant guidance directions relative to the patient position via a remote processor and display enabling accurate reaming and placement of the acetabular cup placement device associated with hip arthroplasty or similar.

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

abbott medical australia pty ltd - 35852 - defibrillator, implantable, automatic - the unify assura cd3361-40c is a cardiac resynchronisation therapy device with rf telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and single site pacing. it features an is-1/df-1 device header and parylene coating. the unify assura cd3361-40c is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. cardiac resynchronization therapy devices (crt-ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. also at/af detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of af.

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

abbott medical australia pty ltd - 35852 - defibrillator, implantable, automatic - the unify assura cd3361-40qc is a cardiac resynchronisation therapy device with rf telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and single site pacing. it features a df4 device header and parylene coating. the unify assura cd3361-40qc is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. cardiac resynchronization therapy devices (crt-ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. also at/af detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of af.

Australia - inglés - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - trenbolone acetate; oestradiol - parenteral implant, device - trenbolone acetate steroid-anabolic active 140.0 mg/im; oestradiol steroid-estrogen active 28.0 mg/im - nutrition & metabolism - steer (castrated male cattle) | beef | bovine | bullock (young) | male cattle - castrated - improve feed efficiency | promote animal growth | feed conversion | finishing | growth promotion | growth rate | liveweight gain