Австралия - английски - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 44855 - prosthesis, hip, internal, femoral head component - a sterile ceramic (biolox delta alumina matrix composite) femoral ball head packaged with a titanium alloy (tial6v4) sleeve. the sleeve is designed to reduce the effect of stem taper imperfections where the stem taper has minor damage and acts to ensure even distribution of stresses on the inside of the femoral ball head. the sleeve has a skirt free design so as not to affect the range of motion. the combined ball head and sleeve are placed on a clean, dry stem taper and impacted into place. the biolox? option system consists of a sleeve and a biolox delta ceramic femoral head with a conical bore which is matched to the sleeve. the biolox option system is used to reposition a ceramic femoral head during cup revisions or when replacing a femoral head on a prosthesis stem left in situ. the biolox option system can also be used for primary surgery to correct the length of the neck.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 38156 - ceramic femoral head prosthesis - biolox delta option ceramic modular head components are comprised of a transition-toughened-platelet alumina composite ceramic (ttpa) material with a highly polished surface available in a variety of head sizes. the highly polished surface is designed to reduce friction and minimize wear. the biolox delta option femoral head component mates with the titanium alloy type 1 or type 12/14 neck sleeve taper adaptor for both primary and revision total hip arthroplasty biolox delta option ceramic modular head components are indicated for use either with ceramic acetabular inserts for ceramic on ceramic articulation or with biomet?s range of ultra high molecular weight polyethylene acetabular liners and cups. they may also be used with exceed abt m2a metal inserts for ceramic on metal articulation. indications for use include: 1. non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and post-traumatic arthritis. 2. rheumatoid arthritis. 3. correction of functional deformity. 4. treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. revision procedures where other devices or treatments have failed.

Сингапур - английски - HSA (Health Sciences Authority)

argon medical asia pte. ltd. - cardiovascular - the device is indicated for the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) in the following conditions:pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy in thromboembolic disease, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. the option filter may be removed in patients who no longer require a filter. retrieval of the filter can only be performed by the jugular approach. the angiographic vessel dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

medacta australia pty ltd - 44855 - prosthesis, hip, internal, femoral head component - the mectacer biolox option femoral heads are made of high-purity aluminium oxide ceramic compound. they are designed to be used in primary and revision hip surgery. the components are bioinert, biocompatible, biostable, mechanically stable, corrosion-resistant and they avoid allergic reactions. they exhibit excellent fatigue strength, high shock and tensile strength, excellent breaking strength, and extreme hardness. the mectacer biolox option system can be used for primary total hip replacement or hemiarthroplasty (partial replacement) to correct the length of the neck, and revision surgery to reposition a ceramic femoral head during cup revisions or when replacing a femoral head on a prosthesic stem left in situ.

Австралия - английски - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ceva animal health pty ltd - ethylestrenol - oral solution/suspension - ethylestrenol steroid-estrogen active 15.0 mg/4g - endocrine system - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - anabolic steroid | abortion threat | androgenic properties | bone repair | catabolic complications | convalescence | erythropoietic activity | geriatric therapy | improve appetite | male sexual characterisitics | muscle development | non-virilising anabolic | pathophysiological process | protein and mineral anabolic | skeletal conditions | tissue breakdown | tissue repair | virilising anabolic

Австралия - английски - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 38156 - ceramic femoral head prosthesis - 44mm, 16/18 taper femoral head component comprised of a transition-toughened-platelet alumina composite ceramic (ttpa) material with a highly polished surface. the highly polished surface is designed to reduce friction and minimize wear. the biolox delta option femoral head component mates with the titanium alloy type 1 or type 12/14 neck sleeve taper adaptor for both primary and revision total hip arthroplasty. only intended for use as ceramic on poly construct. 44mm delta option ceramic head indicated for use as part of total hip replacement construct. when used with g7 acetabular system, this size is only indicated for ceramic on polyethylene use. indications for use include: non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and post-traumatic arthritis; rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other devices or treatments have failed.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 32831 - uncoated knee femur prosthesis - nexgen? complete knee solution legacy? knee lps femoral component, option is used in total knee arthroplasty where both cruciate ligaments are excised. it is made of zimaloy? cobalt-chromium-molybdenum alloy and is for cemented use only. the nexgen? complete knee solution legacy? knee lps femoral component, option is indicated for patients with severe knee pain and disability due to: - rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - collagen disorders, and/or avascular necrosis of the femoral condyle. - post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - moderate valgus, varus, or flexion deformities. - the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 32831 - uncoated knee femur prosthesis - designed with an extended posterior condyle radius, providing greater tibio-femoral contact area in deep flexion. the increased contact area reduces the possibility of point loading as flexion approaches 155?. indicated for use with lps-flex prolong articular surfaces. manufactured from tivanium? ti-6al-4v alloy with a ti-nidium? surface hardening process. for cemented use only. the nexgen? cks legacy? knee lps-flex femoral component, option w/ ti-nidium? surface hardening process is indicated for patients with severe knee pain and disability due to: - rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis - collagen disorders, and/or avascular necrosis of the femoral condyle - post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy - moderate valgus, varus, or flexion deformities - the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Сингапур - английски - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the wireless dr imaging option - wdr1, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy. it is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or cr systems maybe used. the device is not intended for mammography or fluoroscopy applications.

Нова Зеландия - английски - Ministry for Primary Industries

zoetis new zealand limited - cloxacillin benzathine - cloxacillin benzathine 234 g/kg - antibiotic