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

smith & nephew pty ltd - 43167 - acetabular shell - a sterile titanium noncontinuous spherical shell for non-cemented use only with a triple radius profile and a porous titanium plasma and hydroxyapatite coated outer surface. the cup is oversized by 2-3% in the main anchorage area to allow tight contact in the peripheral shell region and a relatively low contact in the pole region. the shell is impacted into place and additional fixation with low profile headed screws may be required in certain circumstances. an acetabular component of the ep-fit plus press-fit cup system. the ep-fit plus shell ti-plasma/ha is intended to be used for the following indications: ? all forms of arthritis ? progressive loss of function of the hip joint as a result of degenerative posttraumatic or inflammatory/rheumatic destruction of the joint ? femoral head necrosis ? fractures in the region of the femoral neck or hip joint ? status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint replacement

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

smith & nephew pty ltd - 43168 - non-constrained polyethylene acetabular liner - a sterile non-cemented rexpol (highly cross-linked polyethylene) acetabular insert. the ideal insert to be used with the acetabular shell is determined by using insert trials. following trialing, the rexpol insert is impacted using an inserter/impactor or if a 36mm insert is used, it should be placed manually or with the insert positioning instrument. the primary seating of the rexpol insert may be checked using a rasp. an acetabular component of the ep-fit plus press-fit cup system. the ep-fit plus rexpol insert standard is intended to be used for the following indications: ? all forms of arthritis ? progressive loss of function of the hip joint as a result of degenerative posttraumatic or inflammatory/rheumatic destruction of the joint ? femoral head necrosis ? fractures in the region of the femoral neck or hip joint ? status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint replacement

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

smith & nephew pty ltd - 43168 - non-constrained polyethylene acetabular liner - a sterile non-cemented rexpol (highly cross-linked polyethylene) acetabular insert having a raised shoulder of 15 degrees intended as luxation protection. the insert should be positioned in the direction in which there is the greatest risk of luxation and the shoulder position of the insert may be adjusted in 30 degree increments. the rexpol hooded insert is impacted into the acetabular shell using an inserter/impactor. an acetabular component of the ep-fit plus press-fit cup system. the ep-fit plus rexpol insert hooded is intended to be used for the following indications: ? all forms of arthritis ? progressive loss of function of the hip joint as a result of degenerative posttraumatic or inflammatory/rheumatic destruction of the joint ? femoral head necrosis ? fractures in the region of the femoral neck or hip joint ? status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint replacement

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

smith & nephew pty ltd - 48055 - ceramic acetabular liner - a sterile ceramic (al203 zro2) acetabular insert to be used in combination with a ceramic ball head. following trialling with a trial head the insert may be placed into the acetabular shell by hand or with the insert positioning instrument. the alignment guide should be used to aid with positioning. positioning can be verified by making sure the shell and insert sit flush, and the insert is fixed into place using the inserter/impactor. an acetabular component of the ep-fit plus press-fit cup system. the ep-fit plus biolox delta ceramic insert is intended to be used for the following indications: ? all forms of arthritis ? progressive loss of function of the hip joint as a result of degenerative posttraumatic or inflammatory/rheumatic destruction of the joint ? femoral head necrosis ? fractures in the region of the femoral neck or hip joint ? status following earlier operations such as osteosynthesis, corrective osteotomies, stiffening or joint replacement

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

biotronik australia pty ltd - 17898 - cardiac electrophysiology analysis system - it is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related electrophysiological procedures in hospitals or ep-labs. the system allows the user to view and record the signals. the system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

Singapore - English - HSA (Health Sciences Authority)

euro asia medico pte. ltd. - fenofibrate (nanonized) - tablet - fenofibrate (nanonized) 145 mg

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

air liquide healthcare pty ltd - air, quantity: 100 % v/v - gas, medicinal - excipient ingredients: - for normal respiration. in anaesthetic equipment as a carrier gas during surgery. for nebulisation of inhaled drugs when oxygen supplementation is not required.

Singapore - English - HSA (Health Sciences Authority)

biotronik asia pacific pte. ltd. - cardiovascular - the apt ep map-it™ diagnostic mapping catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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

johnson & johnson medical pty ltd - 60784 - cardiac radio-frequency ablation system - to generate radiofrequency current for tissue ablation procedures

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

boston scientific pty ltd - 46355 - electrophysiology cardiac catheter, single-use - the unidirectional steerable diagnostic catheters are radiopaque, flexible, insulated catheters with a polymer shaft. they have a white rotating handle mechanism which provides curve actuation of the distal tip. the unidirectional steerable diagnostic catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.