4 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Israel
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NP CloseFit™ Scan Body 7mm
Device
EU MDR
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Eu Md Class 1
·Adin Dental Implant Systems LTD.·On the market·32 countries
Intrisound Tuned Lumen® 155 Hearing Aids
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial.
FDA Enforcement
Class II
·Terminated·Medimop Medical Projects Ltd.·March 21, 2018
Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.
FDA Enforcement
Class II
·Terminated·S.A.E. AFIKIM·November 6, 2013