Didžioji Britanija - anglų - MHRA (Medicines & Healthcare Products Regulatory Agency)

shire pharmaceuticals ltd - icatibant acetate - solution for injection - 10mg/1ml

Australija - anglų - Department of Health (Therapeutic Goods Administration)

iq medical - 11482 - electroretinograph - an ophthalmic electrodiagnostic device intended to be used to generate stimulus signals and to display the electrical signals generated by the retina and visual nerve system, by recording the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light. the electroretinograph (erg) recorder is used with a primary electrode and a reference electrode located almost anywhere in the body, e.g. cheek or earlobe, and an amplifier that boosts the bioelectrical potential. some recorders are compatible with personal computers (pcs) for waveform storage and analysis. it is used in the diagnosis of retinal degeneration, night blindness, and circulatory disturbances of the retina and can display electroretinograms (erg), viisually evoked potentials (vep), electrooculograms (eog), electronystamography (eng) and pupillography.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

dksh australia pty ltd - ct738 - measles (rubeola) virus ivds - serion elisa classic measles virus igg & igm are an immunoassay test for the determination of igg & igm levels in serum and plasma.. the test is intended to be used by trained personnel in suitably equipped medical diagnostic laboratories.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

dksh australia pty ltd - ct749 - herpes simplex virus (hsv) (human herpesvirus 1 & 2) ivds - the serion elisa herpes simplex virus 1, 2 & 1&2, igg & igm are an enzyme-linked immunosorbent assays intended for the detection of human antibodies, in serum or plasma, directed against herpes simplex virus type 1 or 2. the assay supports the diagnosis and aetiology of acute infections, and assists in the differential diagnosis of diseases and conditions which present with similar symptoms. the test delivers quantitative results and there are no variants of the test. the product is intended to be used by qualified clinical laboratory personnel in suitably equipped laboratories and is capable of being performed manually or on a range of suitable laboratory automated instruments (listed in the instructions for use -ifu)

Australija - anglų - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 47342 - laparoscopic irrigation/aspiration cannula - intended to be used during endoscopy to provide cannulation for the instillation or aspiration of fluid to/from a targeted area of the body.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 45716 - suture knot pusher, reusable - a hand-held manual surgical instrument that enables the user performing an internal suturing procedure to advance suture knots created extracorporeally to the point of appropriate suture tension.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

surgical instruments australia pty ltd - 35325 - scissors, - used for cutting items or tissues.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

surgical instruments australia pty ltd - 32312 - hammer, surgical - hammers (also referred to as mallets) are used in various surgical procedures to impart a force.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

surgical instruments australia pty ltd - 37039 - holder, - a device used to stabilise or support a variety of other devices, usually used in conjunction with surgical procedures/examination of the patient. it may also help to free an operator's hands during procedures.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

surgical instruments australia pty ltd - 13373 - retractor, - a surgical instrument for separating tissue or other anatomical parts to expose or access organs or tissues to permit examination or intervention.