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

life healthcare pty ltd - 33695 - femoral head bipolar component - ic-bipolar heads/bipolar heads (material: inner shell and retainment ring uhmw-pe, outer shell: cocrmo casting alloy. these heads articulate directly with the cartilage of the non-prepared acetabulum. they are matched with an ic titanium, ic crcomo or biolox forte/delta ceramic femoral head that seats within the bipolar head and this head is then attached to a trunion of a femoral stem. a bipolar femoral head component used as part of hemiarthroplasty. the main indications for the insertion of a hemi arthroplasty implant: - femoral neck fractures, - femoral head necrosis.

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

zimmer biomet pty ltd - 33712 - bipolar partial shoulder prosthesis - a sterile implantable artificial substitute for the humeral component of a shoulder joint typically replaced due to injury (e.g., fracture). it includes humeral head and stem components and a humeral head bipolar component (device that articulates with the humeral head prosthesis on one surface and the natural glenoid fossa on the other), typically with parts made of metal and polyethylene (pe). fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - nifedipine - modified-release tablet - 10mg

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

aa-med pty ltd - 44661 - electrode, electrosurgical, active, cardiac ablation, single-use - the isolator is an electrosurgical instrument used for cardiac tissue ablation. when activated, the ablation and sensing unit generator delivers radiofrequency (rf) energy to the linear electrodes on the insulated jaws of the isolator. isolator devices are configured as vascular clamps and feature clamping jaws of various lengths. the isolator synergy clamps feature two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanisms. it is intended to be used to create lesions within the heart to eliminate or reduce cardiac conduction and treat cardiac arrhythmia using radio frequency energy, supplied by a separate generator. it can be used during pulmonary vein isolation and atrial connecting lesions for the maze procedure for the treatment of cardiac arrhythmias including atrial fibrillation. it can also be used for lesions on soft tissue, such as the pulmonary vein.

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

aa-med pty ltd - 32531 - radio-frequency ablation system probe, reusable - the clamps feature two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanisms. when activated the sensing unit delivers radio frequency energy to the linear electrodes on the jaws of the isolator. the clamps have an attachment tip for which glidepath tape that is part of the device is attached. the glidepath tape instrument guide is used to facilitate the guidance of the instrument through the soft tissue. isolator synergy clamps are intended to ablate cardiac tissue during surgery.

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

aa-med pty ltd - 60784 - cardiac radio-frequency ablation system - single patient use electrosurgical instrument designed for use with the atricure ablation and sensing unit (asu) and asu source switch (asb). it is used to ablate cardiac tissues and as a surgical pacing and mapping tool. when connected to the asu, the asu provides the bipolar radiofrequency energy flowing between both electrodes of the pen. when connected to an auxiliary pace, sense, or stimulation, the pen is designed to provide temporary pacing or monitoring. sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (rf) energy when connected directly to the ablation and sensing unit (asu) or asu source switch (asb)in ablation mode. may be used for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

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

aa-med pty ltd - 60784 - cardiac radio-frequency ablation system - single patient use electrosurgical instrument to be used with the atricure ablation and sensing unit (asu2/asu3). when the pen is connected to the asu, the asu provides the bipolar radiofrequency energy flowing between both electrodes of the pen for ablation of cardiac tissue. sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (rf) energy when connected directly to the ablation and sensing unit (asu) or asu source switch (asb) in ablation mode. it may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

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

aa-med pty ltd - 60784 - cardiac radio-frequency ablation system - sterile, single use electrosurgical instrument designed for use with the atricure ablation and sensing unit (asu) and atricure switch matrix (asb). designed with internally cooled electrodes to produce continous, full thick lesions. the asu delivers bipolar radiofrequency energy which flows between the internally cooled electrodes of the coolrail linear pen. sterile, single use electrosurgery device intended to ablate cardiac tissue or soft tissue using radiofrequency (rf) energy.

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

mathys orthopaedics pty ltd - 33175 - metallic femoral head prosthesis - the bipolar head includes a retaining ring. the external component is located in a fixed position in the natural acetabulum and the main articulating motion takes place in the form of a multi-dimensional rotational movement in the articular cavity between the inner head and the inside of the outer shell. in extreme cases there is a sliding movement of the outer shell on the acetabular cartilage. the bipolar principle thus reduces wear of the chondral tissue in the acetabulum. the stainless steel bipolar head is intended to treat fracture or avascular necrosis of the femoral head, or fracture of the femoral neck in cases where composition and morphology of the bone that allows the implant to remain stable

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

medacta australia pty ltd - 33704 - prosthesis, internal, joint, hip, hemi - the bipolar head includes an outer shell made of stainless steel, designed to articulate directly in the patient?s acetabulum, an inner ultra high molecular weight polyethylene (uhmwpe) bearing surface, in which articulates the prosthetic femoral head. the locking of the femoral head inside the bipolar head is easily achieved and assured thanks to an elastic internal retaining ring. the bipolar head is designed for use in partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery.