Singapore - English - HSA (Health Sciences Authority)

aerobe pte. ltd. - neurology - the brain quick bio-potential signal acquisition system product family supports recording, processing and display of bio-potential signals from user supplied electrodes. the system includes both hardware recorders, intended to acquire and temporary store physiological signals for eeg, ep and/or psg and to transfer the data to separate analysis software, and the software which is used for the signal acquisition, display, storage, process and measure of biologic signals. the brain quick system does not make any judgment of normality or abnormality of the displayed signals or the result of an analysis. in no way are any of the functions represented as being in themselves diagnostic. the use of brain quick systems is reserved to physicians, technicians, or other medical professionals that are trained in bio-potential recording.

Singapore - English - HSA (Health Sciences Authority)

demant singapore pte ltd - neurology - the device is used to non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (eng) testing of vestibular function using miniature video camera and pupil tracking hardware. the device is an alternative to skin electrodes and a physiologic signal amplifier for monitoring eye position.

Singapore - English - HSA (Health Sciences Authority)

baxter healthcare (asia) pte ltd - general hospital - the duplospray mis regulator is a re‑usable, non-sterile device intended for regulating gas flow of medical grade vaporous carbon dioxide to assist in the application of surgical sealants.

Singapore - English - HSA (Health Sciences Authority)

baxter healthcare (asia) pte ltd - general hospital - the endoscopic applicator is intended for use in delivering hemostatic agent to bleeding surgical sites through a 5 mm or larger trocar.

Singapore - English - HSA (Health Sciences Authority)

baxter healthcare (asia) pte ltd - general & plastic surgery - the gasless tip is indicated for the application of tisseel fibrin sealant.

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

micromed-international pty ltd - 62439 - dental surgical microscope - a dental microscope intended to be used as an imaging system during dental examination and dental surgical procedures

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

micromed-international pty ltd - 35191 - microscope, surgical, general-purpose - operation microscope to magnify the operation field image during surgical procedures, including taking magnified photos via integrated camera

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

compumedics limited - 36728 - amplifier, electromyograph - the compumedics xegis forte 2-17 channel amplifiers are devices intended to be used for electroencephalography, electromyography and evoked potentials by means of surface or needles electrodes.

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

compumedics limited - 36728 - amplifier, electromyograph - the compumedics xegis g.neo and g.neo ep 2 channel amplifier devices are intended to be used to perform electromyography or evoked potential exams using surface electrodes, needles, and proper headphones and goggles.

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

compumedics limited - 47541 - bioelectrical signal processing application software - xegis software is explicitly designed to help physicians in recording, archiving and reviewing data coming from xegis digital acquisition systems. xegis software can be used for emg and ep exams and other neurophysiological studies based on the data recorded from the patient through xegis acquisition devices. some analysis functional tools are provided as default or software options. results coming from these tools must never substitute the critical interpretation and the clinical conclusions that pertain to the physician only. xegis software is not intended to continuously monitor the central nervous system functionality, in conditions where a warning on the change of patient condition is essential (e.g. or and icu automatic monitoring without the presence of the physician), since it is not endowed with proper alarms that substitute continuous medical surveillance. the use of xegis software must always be carried out under the supervision of a physician or a qualified technician.