Medical devices

Safety warning for the medical device "Raindrop Near Vision Inlay".

Safety warnings | Medical devices | 22/01/2019
The product "Raindrop Near Vision Inlay" is a medical device for the treatment of presbyopia. (presbyopia). It is implanted into the cornea of an eye and causes a change in the shape of the cornea. Cornea, which is intended to improve sharp near vision.
Safety warning for the medical device "Raindrop Near Vision Inlay". Read more

Safety warning for medical devices of the manufacturer LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H.

Safety warnings | Medical devices | 11/09/2018
The Federal Office for Safety in Health Care (BASG) has been informed that "LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H., Gösserstraße 11, 8700 Leoben" (Logimed), which was liquidated in 2011, has no legal successor who continues to fulfil the manufacturer obligations arising from the Medical Devices Act (MPG), Federal Law Gazette No. 657/1996, as amended. These obligations include Post Market Surveilance System (PMS), which includes the investigation of incidents and, where appropriate, the initiation of safety corrective actions in the field.
Safety warning for medical devices of the manufacturer LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H. Read more

Safety warning concerning Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series nebuliser

Safety warnings | Medical devices | 18/07/2018
The BASG has been approved by the competent authority in Great Britain (Medicines & Healthcare products Regulatory Agency - MHRA) informs that the products listed are unlawfully available on the market. were brought. The manufacturer has not provided sufficient evidence that the products comply with the comply with legal requirements.
Safety warning concerning Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series nebuliser Read more
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