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

stryker australia pty ltd - 44759 - fixation system implantation kit, internal - intended to be used as accessories to the stryker spine navigation system, when used with the spinemap 3d navigation software. they are manual surgical instruments intended to be used in spine surgery to facilitate placement of stryker spine implants. may be used as part of the stryker spine navigation system, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. the system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. intended for exclusive use with the rotational navigational adaptor and associated trackers to facilitate the placement of the pedicle screws of the stryker spine xia? 3, xia? 4.5, mantis?, mantis? redux, and es2? spinal fixation systems using the stryker spinemap? 3d navigation system.

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

medtronic australasia pty ltd - 45169 - stereotactic surgery system probe, reusable - an accessory to the mazor x system, the arm guides are intended to accommodate between medtronic spine instruments and navigation navlock trackers while using the mazor x system.

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

emergo asia pacific pty ltd t/a emergo australia - 58884 - self-care monitoring web-based application software - glooko is a data management software intended for use in home and professional settings to aid individuals with diabetes and their healthcare professionals in review, analysis and evaluation of device data to support an effective diabetes management programme. glooko connects to compatible medical devices and trackers to allow users to transfer their data to the glooko system. glooko is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice

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

medtronic australasia pty ltd - 45199 - stereotactic surgery system, multi-purpose - the electromagnetic (em) ent trackers are single-use sterile devices and are intended for use with the medtronic ent software to track the location of suctions, probes, and the head frame in either open or percutaneous procedures.

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

ehc commercial singapore pte. ltd. - dental - the x-guide® surgical navigation system is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra-operative surgical phase of dental implantation procedures. the system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. the device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as part of their treatment plan.

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

medtronic international, ltd. - general & plastic surgery - the fusion™ system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. the fusion™ 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)

philips electronics singapore pte ltd - radiology / imaging - the epiq ultrasound system is intended for: abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), transrectal and transvaginal

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

stryker singapore private limited - radiology / imaging - the stryker nav3 platform is intended to be used as platform for computer assisted surgery as part of the stryker navigation system. the intended use of the complete stryker navigation system is defined by stryker application modules

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

stryker singapore private limited - radiology / imaging - the nav3i platform is a computer workstation that, when used with specific stryker navigation surgical software displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. the clinical setting and target population for the nav3i platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

somnotec (s) pte. ltd. - radiology / imaging - navigation systems from the series scopis navigation systems are localization devices, which support the user in their orientation and ability to locate target structure while performing surgical procedures. the navigation systems of the scopis navigation systems series determine the position of navigated medical instruments as well as target structures in the operation area, showing those as navigation information in radiologic image data. optionally, such structures are shown at their correct position as augmented reality in endoscopic, microscopic or sonographic images.