18 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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TABATABA V2
Device
EU MDD
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Eu Md Class 1
·FIM Médical·On the market·4 countries
VISIOLITE
Device
EU MDR
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Eu Md Class 1
·FIM Médical·On the market·15 countries
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Device
EU MDD
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Eu Md Class 2a
·FIM Médical·On the market·1 country
VISIOLITE MASTER Edition Computerized
Device
EU MDR
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Eu Md Class 1
·FIM Médical·On the market·15 countries
POSTERIOR GLENOID RETRACTOR
Device
EU MDR
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Eu Md Class 1
·FX Shoulder Solutions·On the market
ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER
Device
EU MDR
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Eu Md Class 1
·FX Shoulder Solutions·On the market
VISIOLITE MASTER GT
Basic UDI-DI
EU MDR
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Eu Md Class 1
·FIM Médical·2 devices
TABATABA V2
Basic UDI-DI
EU MDD
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Eu Md Class 1
·FIM Médical·1 device
ADL20 - HDA300
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·FIM Médical·1 device
27671
Certificate
MDD Annex VI·FIM Médical·GMED SAS·2 Basic UDI-DIs
RETRACTOR
Basic UDI-DI
EU MDR
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Eu Md Class 1
·FX Shoulder Solutions·1 device
RASP HOLDER
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·FX Shoulder Solutions·1 device
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
FIM Médical
System producer
🇫🇷 France
FX Shoulder Solutions
Authorized representative
🇫🇷 France·1 Manufacturer
ITENA CLINICAL
Importer
🇫🇷 France·10 Manufacturers
COMED SAS
Importer
🇫🇷 France·25 Manufacturers