Singapore - Tiếng Anh - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended for use by a qualified physician for ultrasound evaluation of abdominal, obstetrical, gynecological, breast, small parts, vascular /peripheral, transcranial, pediatric and neonatal, musculoskeletal, urological, cardiac

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

corin australia pty ltd - 40805 - marker, image identification, manual - omnibotics tracker kit includes reflective marker that is manually configured and physically placed within the field of view of a medical imaging system and leaves identifying marks on digital images created using image-guided surgery system for use in orthopaedic surgery. reflective markers are placed on the navigation references of the navigation system. they are made from materials compatible with the imaging system with which it is intended to be used and is a single use sterile product.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - ct943 - instrument/analyser ivds - the instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. the instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. for applications in human medicine, only the magellan tracker software is intended for the use with the instrument. software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative enzyme-linked immunosorbent assays (elisa) according to the scheduled diagnostic parameters and instrument specifications; they are therefore intended for professional use in in-vitro diagnostics.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 61405 - surgical navigation device tracking system cranial localizer holder - a device intended for rigid fixation of a patient tracker to the skull.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 45169 - stereotactic surgery system probe, reusable - an accessory to the mazor x system, a mounting screw is intended to secure a tracker to the arm guide while using the mazor x system.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 45169 - stereotactic surgery system probe, reusable - an accessory to the mazor x system, a tracker is intended to correlate the position of the selected medtronic reference frame with the position of the surgical arm while using the mazor x system.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

cantley medical services pty ltd - 47518 - patient rehabilitation interactive software - wrist tracker for rehabiliation of the affected arm

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

alcon pte ltd - ophthalmology - the wavelight® ex500 is a stationary scanning-spot excimer laser system indicated to be used in refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, mixed astigmatism, including customized refractive surgery based on data delivered by wavelight’s diagnostic devices and phototherapeutic keratectomy (ptk) for indications requiring a ptk treatment. wavenet planning software is intended to administer and edit main patient data, diagnostic and planned data from the wavelight gmbh diagnostic and therapeutic devices decentrally.

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

zimmer pte. ltd. - orthopaedics - computer assisted surgery system intended to assist in positioning orthopedic unicondylar knee replacement implant and instrument components intra-operatively by displaying their positions relative to the bone structures of interest that are modeled pre-operatively from radiology images, or relative to their alignment axes as based on anatomical landmarks that are identified intra-operatively by the user.