Singapore - English - HSA (Health Sciences Authority)

asia medical supplies pte ltd - ear, nose & throat - the provox vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). the provox smartinserter is a sterile single use device intended for anterograde replacement of the provox vega voice prosthesis. the provox smartinserter is not intended to be used for insertion of a voice prosthesis in a freshly made puncture.

Singapore - English - HSA (Health Sciences Authority)

asia medical supplies pte ltd - ear, nose & throat - the provox2 voice rehabilitation system is intended for use in surgical, prosthetic voice restoration after total laryngectomy. the voice prosthesis may be inserted by the physician at the time of the total laryngectomy (primary puncture), or at a later date (secondary puncture), or may be used to replace the present prosthesis.

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

coloplast pty ltd - 36071 - prosthesis, internal, valve, speech, tracheostomy - freevent dualcare system is attached to a tracheostomy tube and is designed to eliminate the necessity of finger occlusion, enabling the tracheostomized patient to speak easily and more clearly.

Singapore - English - HSA (Health Sciences Authority)

asia medical supplies pte ltd - ear, nose & throat - the provox larybutton is a device for vocal and pulmonary rehabilitation after total laryngectomy. trained patients with a shrinking tracheostoma may use it to maintain the tracheostoma for breathing. the provox larybutton acts also as a self-retaining holder for other rehabilitation devices. the provox larybutton sizer kit is intended for use by the prescribing specialist to determine the size(s) of larybutton that should be prescribed to the patient. the sizer larybuttons are intended for the sizing procedure only. after the correct size(es) have been determined, new larybutton(s) shall be used by the patient.

Singapore - English - HSA (Health Sciences Authority)

asia medical supplies pte ltd - ear, nose & throat - the provox nid voice prosthesis system is intended for use in prosthetic voice rehabilitation after total larynegectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the ifu without the clinician supervision. the provox nid is intended for a single patient use.

Singapore - English - HSA (Health Sciences Authority)

asia medical supplies pte ltd - ear, nose & throat - the provox larytube is a holder for devices in the provox hme system intended for vocal and pulmonary rehabilitation after total laryngectomy. for patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. the provox larytube is intended for single patient use

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

coloplast pty ltd - 60494 - medical adhesive remover, non-sterile - a non-sterile liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient?s skin. after application, this device cannot be reused.

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

atos medical pty ltd - 17802 - exerciser, jaw - therabite is a hand-operated jaw mobilisation and resistance device with adjustable opening range and speed designed to regin mobility and strength the jaw.

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

atos medical pty ltd - 33794 - tube, tympanostomy - intended to replace or restore function to the tympanic membrane thus providing temporary ventilation of the middle ear and or/drainage of fluids from the middle ear into the external auditory canal.

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

atos medical pty ltd - 42533 - tracheoesophageal speech valve, indwelling - the device is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). cleaning of the voice prosthesis is performed by the patient while it remains in situ. the device has a one-way valve that keeps a te-puncture open for speech and reduces the risk of liquid and food entering the trachea. the device is available in different flange sizes to manage leakage around the site and conform to the tissue around the puncture site accommodating for patient anatomical variations.