18 results · 19ms · Sources: EU EUDAMED, US FDA

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TABATABA V2

Device
EU MDD · Eu Md Class 1 ·FIM Médical·On the market·4 countries

VISIOLITE

Device
EU MDR · Eu Md Class 1 ·FIM Médical·On the market·15 countries

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Device
EU MDD · Eu Md Class 2a ·FIM Médical·On the market·1 country

VISIOLITE MASTER Edition Computerized

Device
EU MDR · Eu Md Class 1 ·FIM Médical·On the market·15 countries

POSTERIOR GLENOID RETRACTOR

Device
EU MDR · Eu Md Class 1 ·FX Shoulder Solutions·On the market

ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER

Device
EU MDR · Eu Md Class 1 ·FX Shoulder Solutions·On the market

VISIOLITE MASTER GT

Basic UDI-DI
EU MDR · Eu Md Class 1 ·FIM Médical·2 devices

TABATABA V2

Basic UDI-DI
EU MDD · Eu Md Class 1 ·FIM Médical·1 device

ADL20 - HDA300

Basic UDI-DI
EU MDD · 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 · 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