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

baxter healthcare pty ltd -

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

sonic innovations (a division of audmet australia) also trading as sonic equipment -

Singapore - englanti - HSA (Health Sciences Authority)

zimmer pte. ltd. - orthopaedics - indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. the temporary prosthesis is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. the device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). the hemi-hip femoral prosthesis is not intended for use more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.) because of inherent mechanical limitations of the device material (polymethylmethacrylate/gentamicin), the molded temporary prosthesis is only indicated for compliant patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Singapore - englanti - HSA (Health Sciences Authority)

covidien private limited - general hospital - it is intended to reduce the risk of kinking when a patient’s head is in an extended or flexed position. suitable for both oral and nasal intubation.

Singapore - englanti - HSA (Health Sciences Authority)

gc asia dental pte ltd - dental - everstick fibre reinforcement is intended for fibre reinforcement recommended for the following applications: everstickc&b: inlay, onlay, full coverage and hybrid bridges; surface-retained bridges; temporary bridges; bridges made indirectly at the chairside or in a dental laboratory; reinforcement and repair of removable dentures and appliances everstickperio: periodontal surface-retained and intracoronal splints: lingual/palatal splints; labial splints; occlusal splints eversticknet: labial periodontal splinting; labial splinting of traumatized teeth; veneer repairs everstickpost: curved and oval root canals as well as in very large canals; traditionally prepared and enlarged root canals

Singapore - englanti - HSA (Health Sciences Authority)

emmed pte ltd - general & plastic surgery - neoveil sheet type is intended for reinforcing and preventing air leakage of the suturing region and stapling region. it is indicated for (a) reinforcement for regions which do not take a long time to heal, (b) reinforcement for regions of weak tissues in thoracic, abdominal and oral surgery, and (c) prevention of air leakage from the lung, bronchi and diaphragm, where such prevention is difficult to perform by only using sutures or surgical staplers. neoveil tube type is intended for reinforcing and preventing air leakage of the stapling region. it is indicated for (a) reinforcement for regions which do not take a long time to heal, (b) reinforcement for regions of weak tissues in thoracic and abdominal surgery, and (c) prevention of air leakage from the lung, bronchi and diaphragm, where such prevention is difficult to perform by only using surgical staplers.”

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

w l gore & associates (australia) pty ltd - 44688 - mesh, polymeric, biodegradable - a circular mesh disc suitable for use with circular staplers. to support or protect soft-tissue in a surgical procedure and/or as a temporary scaffold for tissue regeneration.

Singapore - englanti - HSA (Health Sciences Authority)

covidien private limited - anaesthesiology - intended for use in providing tracheal access for airway management in conjunction with a medical need to perform a tracheotomy.

Singapore - englanti - HSA (Health Sciences Authority)

raintree medical pte. ltd. - general hospital - skin closure strips are intended to approximate edges of superficial wounds

Singapore - englanti - HSA (Health Sciences Authority)

teleflex medical asia pte. ltd. - general hospital - it is intended for oral or nasal intubation for airway management. this device may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.