Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - ammonia solution strong; ammonia solution aromatic; phenol liquefied - cutaneous cream - 1mg/1gram ; 60.4mg/1gram ; 4.94mg/1gram

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - lidocaine hydrochloride; cetylpyridinium chloride - oromucosal gel - 3.3mg/1gram ; 1mg/1gram

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

connexion surgical pty ltd - 38161 - spinal cage - intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. to be used with bone graft material packaged within the implant to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. for degenerative disc disease (ddd) at one or multiple levels from l2 to s1. these ddd patients may also have grade 1 and potentially grade 2 or 3 spondylolisthesis at the involved levels. ddd is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. these patients should be skeletally mature and have had six months of non-operative treatment.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 34170 - prosthesis, internal, spine, vertebral body - the capstone control ptc spinal system is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease(ddd) at one or two levels from l2 to s1. these ddd patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. these patients should be skeleteally mature and have six months on non-operative treatment. these implants may be implanted via an open or a minimally invasive posterior approch. alternatively, these implants may also be implanted via an anterior and/or transforaminal approch. these implants are to be used with autogenous bone graft.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - oto dr pacemaker is dddr-type dual-chamber rate responsive pacemaker. it is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient?s activity oto dr pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree av block; symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias, vasovagal syndromes or hypersensitive carotid sinus syndromes. dual-chamber and atrial tracking modes in patients who may benefit from maintenance of av synchrony. dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony. the device(s) are mr conditional in the 1.5t and 3t mr environment.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - eno dr pacemaker is dddr-type dual-chamber rate responsive pacemaker. it is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient?s activity eno dr pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree av block; symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias, vasovagal syndromes or hypersensitive carotid sinus syndromes. dual-chamber and atrial tracking modes in patients who may benefit from maintenance of av synchrony. dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony. the device(s) are mr conditional in the 1.5t and 3t mr environment.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - teo dr pacemaker is dddr-type dual-chamber rate responsive pacemaker. it is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient?s activity teo dr pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree av block; symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias, vasovagal syndromes or hypersensitive carotid sinus syndromes. dual-chamber and atrial tracking modes in patients who may benefit from maintenance of av synchrony. dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony. the device(s) are mr conditional in the 1.5t and 3t mr environment.

Szingapúr - angol - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the nuvasive coroent system is indicated for intervertebral body fusion of the spine in skeletally mature patients. the system is designed for use with autogenous bone graft to facilitate fusion. the coroent l and xl platforms are intended for use at either one level or two contiguous levels in the lumbar spine, from l2 to s1, for the treatment of degenerative disc disease (ddd) with up to grade i spondylolisthesis. ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. the lumbar devices are to be used in patients who have had at least six months of non-operative treatment. the system is intended to be used with supplemental internal spinal fixation systems that are cleared by the fda for use in the lumbar spine.

Szingapúr - angol - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the nuvasive coroent system is indicated for intervertebral body fusion of the spine in skeletally mature patients. the system is designed for use with autogenous bone graft to facilitate fusion. the coroent s platforms are intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (ddd) at one level from levels c2-c3 to c7- t1. the cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. the system is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

evolution surgical pty ltd - 46653 - spinal fixation plate, non-biodegradable - the choice spine plates are spinal implants for surgical stabilisation of the anterior spine. the products are indicated for degenerative disc disease (ddd) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.