5 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: France
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1-FIX
Device
EU MDR
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Eu Md Class 1
·Poirot Plastique Industrie Médical·On the market
Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Fx Solutions·July 25, 2018
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Fx Solutions·July 25, 2018
NATECH
Importer
🇫🇷 France·11 Manufacturers
BIOSYNEX
Importer
🇫🇷 France·19 Manufacturers