Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

teleflex medical australia pty ltd - 36257 - catheter, central venous, peripherally inserted - facilitate visual navigation of a picc. the stylet is placed inside the central venous catheter, an electromagnetic t-piece is placed on the patient sternum. ecg technology is used to track the location of the picc. a blue line is displayed on the vps rhythm screen which shows the picc pathway the t-piece has a radius of approx 22cm and will identify the stylet once it appears within that range. as the catheter approaches the heart ecg waveforms are used to determine final catheter tip locatio the pressure injectable (pi) picc is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. the maximum pressure of pressure injector equipment used with the pi picc may not exceed 300 psi (2068.4 kpa). the pi picc is preloaded with arrow vps tiptracker stylet to provide catheter tip location information in-situ using the patient?s cardiac electrical activity when connected externally to the arrow visual positioning system (vps) rhythm device.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd -

Ai Cập - Tiếng Anh - EDA (Egyptian Drug Authority)

مصر سينا للتوريدات -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

mac surgical - 61410 - surgical navigation device tracking system instrument localizer connector - a non-sterile component of a surgical navigation device tracking system (e.g., optical device tracking system, electromagnetic device tracking system) intended for holding/affixing a localizer/tracker (e.g., infrared light reflector) to a navigated surgical instrument (e.g., a stereotactic surgery system probe) during computer assisted surgery (cas); it is affixed via dedicated screws. it is typically made of titanium (ti) and may be in the shape of a handle to facilitate handling the instrument during a procedure. this is a reusable device intended to be sterilized prior to use. primary code and term 61410 - surgical navigation device tracking system instrument localizer connector

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

nobel biocare australia pty ltd - 44901 - torque wrench, manual, dental - a hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. it may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. it is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. this is a reusable device.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 60656 - rectal ultrasound navigational image processor - the system is intended to be used by physicians in a clinic or hospital for 2d and 3d visualization of ultrasound images of the prostate gland. the software provides additional features such as patient data management, multi-planar reconstruction, segmentation, image measurement, and 3d image registration. the system is essentially comprised of a tracker assembly, monitor, and cart. the tracker assembly includes an extendable stabilizer arm, tracker and cradle assembly with insert. the monitor includes touch screen monitor, monitor arm, vertical adjustment switch, and stabilizer arm lock button. the cart includes internal pc-based workstation, lockable wheels and footswitch.

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

masimo asia pacific pte. ltd. - general hospital - the centroid™ system is intended for monitoring the orientation and activity of patients. the centroid system is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. the centroid system is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. the centroid system is intended for use in healthcare environments. the centroid system is also indicated for the measurement of respiration rate of adults in healthcare environments.

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

medtronic international, ltd. - neurology - intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. the stealthstation® system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a ct or mr based model, fluoroscopy images, or digitized landmarks of the anatomy.

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

karl storz endoscopy singapore sales pte. ltd. - ear, nose & throat - the karl storz navigation panel unit (npu) system is a positioning aid for navigation in ent surgery. it comprises a planning and treatment program in which an instrument is navigated on the basis of radiological image data (from a ct, mri or dvt). the radiological data is displayed as a function of the position of the instrument and the position of the instrument is shown in the radiological data. any other use other than as outlined above and explicitly described in the instruction manual is not permitted.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

regeneron pharmaceuticals, inc. - casirivimab (unii: j0fi6we1qn) (casirivimab - unii:j0fi6we1qn) - treatment the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to permit the emergency use of the unapproved product, regen-cov (casirivimab and imdevimab) co-formulated product and regen-cov (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate coronavirus disease 2019 (covid-19) in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct sars-cov-2 viral testing, and who are at high risk for progression to severe covid-19, including hospitalization or death. limitations of authorized use - regen-cov is not authorized for treatment of mild to moderate covid-19 in geographic regions where infection is likely to have been caused by a non-susceptible sars-cov-2 variant based on available information such as variant susceptibility to this drug and regional variant frequency. - fda's determination and any updates will be available at: https://www.fda