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

apotex pty ltd - amitriptyline hydrochloride -

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

apotex pty ltd - amitriptyline hydrochloride -

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

apotex pty ltd - amitriptyline hydrochloride -

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

life systems medical pty ltd - 61875 - endoscopic electrosurgical electrode, monopolar, single-use - the nykanen radiofrequency wire is intended to create an atrial septal defect in the heart. the nykanen radiofrequency wire is also intended to create a controlled perforation in heart tissue.

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

life systems medical pty ltd - 32151 - peripheral/coronary vasculature catheter, infusion - the protracktm microcatheter is intended to be used as an exchange guide for converting guidewires or as a standard infusion wire.

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

life systems medical pty ltd - 11490 - electrosurgical system generator, general-purpose - the generator & footswitch is to be used with separately approved radiofrequency devices in general surgical procedures to cut soft tissues.

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

life systems medical pty ltd - 47017 - syringe, general-purpose - the powrsyringe is intended for injecting contrast media during angiographic or other fluoroscopic procedures, but can also be used as a standard syringe for injecting fluids in other types of procedures as well.

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

life systems medical pty ltd - 41651 - electrocardiograph, holter analyser, software - a stand-alone software medical device intended to analyze in a computerized way continuous ecg recordings, visualize, review and edit the analysis and generate clinical reports. it intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. it is a tool to support the clinician in the interpretation of the ecg data and the diagnosis of heart rhythm disorders in adult and pediatric patients. it does not carry out an automated interpretation and is not intended as the only diagnostic tool.

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

life systems medical pty ltd - 47248 - transseptal needle - the safesept transseptal guidewire? is a nitinol guidewire designed to cross the interatrial septum when supported by a transeptal introducer and be atraumatic when advanced unsupported into the left atrium. a radiopaque coil is positioned on the distal end of the device to provide fluoroscopic localization during the procedure. white printed markers are positioned on the proximal end of the device to provide approximate transseptal guidewire tip location relative to the needle tip. the safesept transseptal guidewire? is used in conjunction with a transseptal needle to create the primary puncture in the interatrial septum and to guide the needle, dilator, and introducer through the septum from the right side of the heart to the left side.

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

life systems medical pty ltd - 46455 - torque manipulating device - distal access torque device used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. device is not intended for use in the neurovasculature.