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

medtronic australasia pty ltd - 46425 - bone matrix implant, animal-derived, bioabsorbable - mastergraft? putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a mouldable form of bone void filler. mastergraft? products are biocompatible, osteoconductive, porous implants that allows for bony in growth across the graft site while resorbing at a rate consistent with bone healing. mastergraft? putty is intended to help fill voids or gaps in bone, which may be surgically created osseous defects, or osseous defects caused by traumatic injury to the bone. mastergraft? putty provides a bone void filler that is resorbed and is replaced with bone during the natural healing process. the putty when combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. additionally, mastergraft putty can be used with autograft as a bone extender. specific indications for use include oral/maxillofacial augmentation or reconstruction.

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

global medical solutions australia pty limited - 40646 - nuclear medicine system, hand-held detector - used to detect areas of increased radionuclide uptake during surgery.

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

beckman coulter australia pty ltd - ct907 - histology and cytology ancillary ivds - ivds that are intended to be used alone or in combination with other ivds to perform various histology and cytology-related tests and procedures.

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

beckman coulter australia pty ltd - ct1056 - immunohistology cell marker ivds - ivds that are intended to be used in histology and cytology to provide information about the presence and localisation of specific proteins and antigens

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

beckman coulter australia pty ltd - ct850 - clinical chemistry hormone ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of clinical chemistry hormones in a clinical specimen.

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

beckman coulter australia pty ltd - ct1242 - troponin ivds - the access hstni assay and calibrator systems are a chemiluminescent immunoassay for high sensitivity quantitative determination of cardiac troponin i (ctni) levels in human serum and plasma using the access immunoassay systems to aid in the diagnosis of myocardial infarction (mi).

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

blackaby diagnostics pty ltd - ct1236 - clinical chemistry biological screening ivds - an in-hospital / in-laboratory immunochromatographic rapid test inclusive of cassette and buffer for the qualitative detection of human haemoglobin in human faecal specimens. this kit is intended for use as an aid in the diagnosis of lower gastrointestinal pathologies such as colorectal cancer and its previous stages.

Malta - English - Medicines Authority

lab. chimico farmaceutico a sella s.r.l via vicenza 67, schio, italy - glycerol - suppository - glycerol - drugs for constipation