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

medacta australia pty ltd - 60826 - custom-made orthopaedic surgical guide, non-sterile - devices intended to be used as anatomical guides specific for a single patient?s anatomy to assist in the positioning of pedicle screws in the vertebral body intraoperatively.

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

stryker australia pty ltd - 62215 - custom-made anatomy model - anatomical bone model intended to be used by the surgeon as an anatomical reference in planning and performing the implantation of patient-fitted temporomandibular reconstruction prostheses

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

aa-med pty ltd - 62249 - custom-made anatomy model/surgical guide kit - cmf plastic guides and cmf orthognatic splints are intended to be used as surgical tools to transfer a preoperative plan to surgery. cmf plastic guides are intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. cmf orthognatic splints are intended to align the maxilla and/or mandible in orthognathic surgical procedures. the subject devices are intended for single use only.

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

johnson & johnson medical pty ltd t/a depuy synthes - 60826 - custom-made orthopaedic surgical guide, non-sterile - intended to guide the marking of bone and/or guide surgical instruments.

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

iorthotics pty ltd - 62870 - orthotic insole, custom-made - we manufacture and 3d print custom foot orthotics for podiatrists. these devices are made using 3d scan data submitted along with a prescription from the podiatrist. we use cad software to design the 3d devices and print in pa11 nylon, on our hp mjf printers, or mill eva using our cnc routers.

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - sodium cromoglicate - eye drops, solution - other antiallergics; cromoglicic acid

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - sodium cromoglicate - eye drops, solution - other antiallergics; cromoglicic acid

Singapore - English - HSA (Health Sciences Authority)

aerobe pte. ltd. - neurology - the brain quick bio-potential signal acquisition system product family supports recording, processing and display of bio-potential signals from user supplied electrodes. the system includes both hardware recorders, intended to acquire and temporary store physiological signals for eeg, ep and/or psg and to transfer the data to separate analysis software, and the software which is used for the signal acquisition, display, storage, process and measure of biologic signals. the brain quick system does not make any judgment of normality or abnormality of the displayed signals or the result of an analysis. in no way are any of the functions represented as being in themselves diagnostic. the use of brain quick systems is reserved to physicians, technicians, or other medical professionals that are trained in bio-potential recording.

Singapore - English - HSA (Health Sciences Authority)

demant singapore pte ltd - neurology - the device is used to non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (eng) testing of vestibular function using miniature video camera and pupil tracking hardware. the device is an alternative to skin electrodes and a physiologic signal amplifier for monitoring eye position.