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

zimmer biomet pty ltd - 18033 - irrigation tip, surgical mist - a device that delivers rinsing fluid to clear blood from a specific area of a surgical site, for example, by delivering a combined stream of air and mist.

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

zimmer biomet pty ltd - 10455 - bone cutter - a surgical instrument used to cut bone ie penetrate/separate bone, during orthopaedic surgical procedures. this device must be sterilized before use. this is a single-use device.

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

zimmer biomet pty ltd - 38678 - robotic surgical system - a surgical system intended for use as a device which uses diagnostic images, for example ct scans, of the patient to assist with pre-surgical planning. it consists of a robotic surgical tool, with an arm for instrument manipulation. this device is intended to assist the surgeon in bone preparation, for example as an alternative to manual broaching/reaming techniques. it is used prior to the placing of the implant by the surgeon in orthopaedic surgery.

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

zimmer biomet pty ltd - 13117 - probe, - a device designed to be used to acquire information in a exploratory/investigative manner. for example, a slender rod-like shaped instrument used in system calibration.

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

zimmer biomet pty ltd - 13180 - orthopaedic prosthesis implantation instrument, reusable - a reusable surgical instrument used to aid in the navigation/placement of instruments or other devices during orthopaedic surgical procedures.

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

stryker australia pty ltd - 46352 - stent, vascular, intracranial - the surpass evolve flow diverter system is comprised of a self-expandable braided implant preloaded on a delivery wire, housed inside an introducer sheath. interwoven with the cobalt chromium wires of the implant are platinum-tungsten wires for visualization under fluoroscopy. once released from the microcatheter into the vessel, the implant expands to the vessel lumen diameter and can be recaptured and repositioned for full deployment. the implant diverts the blood flow away from the aneurysm. the surpass evolve flow diverter system is indicated for use for the treatment of saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter greater than or equal to 2.0mm and less than or equal to 5.0mm

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

emergo asia pacific pty ltd t/a emergo australia - 47699 - cardiac electrophysiology application software - the fitbit ecg app is a software-only medical device used as a spot check to create, record, display, store and analyze an ecg. the fitbit ecg app (working name: ecg spot check) consists of a device application (?device app?) integrated on a consumer fitbit wrist-worn product and a mobile application tile (?mobile app?) on fitbit?s consumer mobile application. the device app uses data from non-medical grade electrical sensors on a consumer fitbit wrist-worn product to create and record an ecg. the algorithm on the device app analyzes a 30-second recording of the ecg and provides results to the user. users are able to view their past results as well as a pdf report of the waveform similar to a lead i ecg on the mobile app. intended purpose: the fitbit ecg app is intended to allow the user to record a waveform similar to a single lead ecg that is then classified as sinus rhythm or atrial fibrillation (af) on a classifiable waveform. the ecg and rhythm classification is not recommended for users with other known arrhythmias. the fitbit ecg app is intended for home use by lay people aged 22 years and over.

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

stryker australia pty ltd - 17846 - catheter, intravascular, guiding - the axs infinity ls plus long sheath is single lumen, flexible, variable stiffness long sheath. it has a radiopaque marker band on the distal end and a luer hub at the proximal end. the axs infinity ls plus long sheath shaft has a 10 cm lubricious coating at the distal end to reduce friction during use. the inner lumen of the axs infinity ls plus long sheath is compatible with 6f or smaller catheters. indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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

stryker australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the retriever consists of a flexible, tapered core wire with a shaped section at the distal end. platinum markers at the distal end allow fluoroscopic visualization. the shaped section is also radiopaque. the retriever delivery wire has a hydrophilic coating on the distal 101cm to reduce friction during use. the retriever has a shaft marker to indicate proximity of retriever tip relative to microcatheter tip. a torque device is provided to facilitate manipulation and retrieval. 1. the trevo? retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (iv t-pa). endovascular therapy with the device should start within 6 hours of symptom onset. 2. the trevo retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment. 3. the trevo retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ica) or middle cerebral artery (mca)-m1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc for age ?80 years). endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy.

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

ortho-clinical diagnostics australia pty ltd - ct889 - multiple clinical chemistry constituent ivds - ivds intended to be used for the qualitative and/or quantitative determination of multiple analytes (chemical, biological, and/or immunological) from more than one clinical chemistry specialty, in a clinical specimen