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

aa-med pty ltd - 60826 - custom-made orthopaedic surgical guide, non-sterile - custom-made craniofacial guides are designed to fit a specific patient and are intended to be used as surgical tools to transfer a pre-operative plan to surgery. these guides are intended to guide the marking of bone and/or guide surgical instruments in craniofacial surgical procedures. the guides are intended for single use only.

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

more group pty ltd - 62249 - custom-made anatomy model/surgical guide kit - custom made guides and biomodels manufactured by 3d printers intended to be used in surgical procedures, surgical treatment planning, anatomical visualisations, craniomaxillofacial surgical procedures and intraoperative procedures

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

aa-med pty ltd - 60826 - custom-made orthopaedic surgical guide, non-sterile - custom made dental drilling guide designed to fit a specific patient and are intended to be used as surgical tools to transfer a pre-operative plan to surgery. these guides are intended to guide the marking of bone and/or guide surgical instruments in dental procedures. the guides are intended for single use only.

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

singular 3dp pty ltd - 66056 - custom-made lower-limb orthosis - custom-made lower-limb orthosis: the device is an externally-applied wearable appliance constructed with specific characteristics (e.g., size, shape, material), as prescribed by a healthcare provider for a specified patient (custom-made), intended to support and correct deformities of the leg and/or feet. it may be one of numerous different designs and is typically made of synthetic and textile materials. this is a single-patient reusable device.

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

singular 3dp pty ltd - 66056 - custom-made lower-limb orthosis - custom-made lower-limb orthosis: the device is an externally-applied wearable appliance constructed with specific characteristics (e.g., size, shape, material), as prescribed by a healthcare provider for a specified patient (custom-made), intended to support and correct deformities of the leg and/or feet. it may be one of numerous different designs and is typically made of synthetic and textile materials. this is a single-patient reusable device.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

thornton & ross ltd - sodium cromoglicate - eye drops - 20mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - sodium cromoglicate - eye drops - 20mg/1ml

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

omni melbourne - 60826 - custom-made orthopaedic surgical guide, non-sterile - this is a device that contains 3 surgical guides that have been custom made, patient specific and single use as a result of being prepared via a 3-d printing technique using cad/cam technologies. these surgical guides have been specifically designed as an integral single-use device that are intended to be used for locating the anchor pins as part of customising the audentes prosthetic bridge, guiding the osteotomy of the maxilla and/or mandible as well as implanting the dental prosthetic devices which permanently retain the bridge.

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

audentes implant bridge pty ltd - 60826 - custom-made orthopaedic surgical guide, non-sterile - this is a device that contains 3 surgical guides that have been custom made, patient specific and single use as a result of being prepared via a 3-d printing technique using cad/cam technologies. these surgical guides have been specifically designed as an integral single-use device that are intended to be used for locating the anchor pins as part of customising the audentes prosthetic bridge, guiding the osteotomy of the maxilla and/or mandible as well as implanting the dental prosthetic devices which permanently retain the bridge.

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

specifica pty ltd - 60826 - custom-made orthopaedic surgical guide, non-sterile - a non-sterile, custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). it is made of synthetic polymer materials and is typically manufactured by 3-d printing and cad/cam techniques to match the patient-specific contours of the target anatomical site. this is a single-use device intended to be sterilized prior to use.