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

smith & nephew pty ltd - 38155 - press-fit femoral stem prosthesis - the redapt sleeveless monolithic revision stem is a tapered, forged titanium (ti-6al-4v) stem with rocktite distal flutes for improved diaphyseal fixation in all bone types and having a 12/14 taper head and a circulotrapezoidal neck for increased range of motion. it is used without cement. the redapt sleeveless monolithic revision stem is a femoral stem component of the redapt revision femoral system intended for use in revision hip surgery. it is intended to be used without cement. indications for use hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip

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

smith & nephew pty ltd - 61556 - sleeve femoral/tibial extension, coated - the redapt sleeved monolithic stem utilizes modular sleeves, where the surgeon can elect to use a sleeved stem in cases where there is proximal/distal mismatch. redapt sleeves are designed to provide secondary proximal support to the distal fixation and enhance implant stability. the titanium conical sleeves in extra small sizes are available with grit blast finish and hydroxyapatite (ha) coating. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity. the redapt? revision femoral hip system is intended to be used without cement. the redapt revision hip system is indicated for revision surgery only.

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

smith & nephew pty ltd - 61556 - sleeve femoral/tibial extension, coated - the redapt sleeved monolithic stem utilizes modular sleeves, where the surgeon can elect to use a sleeved stem in cases where there is proximal/distal mismatch. redapt sleeves are designed to provide secondary proximal support to the distal fixation and enhance implant stability. the titanium conical sleeves in small, medium and large sizes are coated with stiktite and hydroxyapatite (ha). hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity. the redapt? revision femoral hip system is intended to be used without cement. the redapt revision hip system is indicated for revision surgery only.

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

smith & nephew pty ltd - 38155 - press-fit femoral stem prosthesis - the redapt sleeved monolithic stem is a tapered, distally fixed femoral stem that is manufactured from forged titanium alloy (ti-6al-4v) and has a grit blast finish. the redapt sleeved monolithic stem features a non-modular, fixed neck; the stem utilizes modular sleeves, where the surgeon can elect to use a sleeved stem in cases where there is proximal/distal mismatch. it has a 12/14 neck taper design. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity. the redapt? revision femoral hip system is intended to be used without cement. the redapt revision hip system is indicated for revision surgery only.

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

smith & nephew pty ltd - 43167 - acetabular shell - the redapt modular shell, for use in primary and revision tha, is a cementless titanium acetabular shell. the redapt modular shellis manufactured from titanium alloy, ti-6al-4v (astm f1472/iso 5832-3). it has an outer porous structure. the redapt modular shell is to be implanted without bone cement. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

garec -

Singapore - English - HSA (Health Sciences Authority)

radiance medical systems - gastroenterology & urology - the focal one is designed to deliver high intensity focused ultrasound (hifu) energy to the prostate, resulting in thermal destruction of prostate tissue. it is indicated for curative treatment of localised prostate cancer. alternative treatments available to urologists with focal one are: - first-line treatment for patients who are not candidates for surgery or who have refused surgery. - treating local recurrence after radiotherapy and hifu

Singapore - English - HSA (Health Sciences Authority)

radiance medical systems - gastroenterology & urology - is intended to fragment stones in the kidney (renal pelvis and renal calyces) and the ureter (upper, middle and lower ureter). the eswl_l8 table is intended for extracorporeal shock wave lithotripsy (eswl) procedures in conjunction with the diagnostic and therapeutic module of the platform. the teu table is intended for urological diagnostics, endourological procedures and extracorporeal shock wave lithotripsy (eswl) procedures in conjunction with the diagnostic and therapeutic module of the platform.

Singapore - English - HSA (Health Sciences Authority)

radiance medical systems - general hospital - sonolith i-sys is manufactured to fragment stones which are localized in the urinary tract, i.e.kidneys (renal pelvis and calyces) and the ureter (upper, medium and lower ureter). it may also be used for simple endourology procedures. this device allows to treat adults, teenagers and children patients.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

litha pharma (pty) ltd - tablet - see ingredients - each tablet contains caffeine 30 mg codeine phosphate 10 mg doxylamine succinate 5 mg paracetamol 450 mg