Singapore - English - HSA (Health Sciences Authority)

baxter healthcare (asia) pte ltd - general hospital - y-connector is an accessory for haemodialysis. its intended use is to be used with or to be connected to lines for haemodialysis. it introduce additional features to allow administration of infusion liquids or the connection to other device or the addition of components to the original line or the collection of fluid at the end of the line during the priming operations (model no. s-660-c)

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended to be used for head, whole body computed tomography applications. the system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including axial, cine, helical (volumetric), cardiac, and gated acquisitions. these images may be obtained either with or without contrast. this device may include signal analysis and display equipment, patient and equipment supports, components and accessories. this device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. further the images can be post processed to produce additional imaging planes or analysis results. the system is indicated for head, whole body, cardiac and vascular x-ray computed tomography applications in patients of all ages.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the system is intended to be used for head, whole body computed tomography applications. the system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including axial, cine, helical (volumetric), cardiac, and gated acquisitions. these images may be obtained either with or without contrast. this device may include signal analysis and display equipment, patient and equipment supports, components and accessories. this device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. further the images can be post processed to produce additional imaging planes or analysis results. the system is indicated for head, whole body, cardiac and vascular x-ray computed tomography applications in patients of all ages.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - hematology - the rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. rapidlab 1240 can determine the following parameters: ph, pco2, po2.

Singapore - English - HSA (Health Sciences Authority)

spacelabs healthcare pte. ltd. - general hospital - the ultraview sl monitor system are intended to be used for monitoring of multiple physiological parameters for patients of any age ranging from neonates through adults. in addition to monitoring physiological parameters, these devices also support recording and alarming for those parameters. st segment monitoring is restricted to adult patients only.

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

zimmer biomet pty ltd - 43390 - sterile fluted surgical drill - accessory drill kit is intended for creating hole in bone with fluted and spade cutting edge. the kit contains one guidewire and one cannulated drill bit.

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

bio-rad laboratories pty ltd - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - the access hiv combo assay is intended to be used as an aid in the diagnosis of hiv-1 or hiv-2 infection and as screening test for blood and plasma donors. this assay is not intended for testing or screening pooled specimens. an access hiv combo assay result does not distinguish between the detection of hiv-1 p24 antigen, hiv-1 or hiv-1-o or hiv-2 antibodies.the access hiv combo assay is a sequential two-step immunoenzymatic (?sandwich?) assay the access hiv combo assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative detection of hiv-1 p24 antigen and antibodies to hiv-1 (groups m and o) and hiv-2 in human serum and plasma (li heparin), using the access immunoassay systems.

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

karl storz endoscopy australia pty ltd - 35979 - endoscope accessory, cleaning brush, reusable - accessories intended to allow cleaning of reusuable endoscopes.

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

arcadia corporation pty ltd eizo oceania - 36513 - x-ray system, diagnostic, mammographic, accessory, stereotactic unit - accessory for eizo medical lcd monitor providing comfort lighting for reading rooms.

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

bio-rad laboratories pty ltd - 48449 - hiv1/hiv2 antigen/antibody ivd, control - the access hiv combo qc4 & qc5 is intended for monitoring system performance of the access hiv combo assay. the access hiv combo qc4 & qc5 is intended for monitoring system performance of the access hiv combo assay.