552 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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Goodman Co. Ltd.
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device
Saraya Co., Ltd.
Manufacturer
🇯🇵 Japan
LCD chart LCD-1000
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Rexxam Co.,Ltd·2 devices
Ohira Co.,Ltd.
Manufacturer
🇯🇵 Japan·3 Basic UDI-DIs·7 Devices·15 Importers·SGS Belgium NV
Rexxam Co.,Ltd
Manufacturer
🇯🇵 Japan·3 Basic UDI-DIs·6 Devices·18 Importers
TOWA MEDICAL INSTRUMENTS CO.,LTD.
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·15 Importers·SGS FIMKO OY
FINDEX Inc.
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device·8 Importers
LED Slit Lamp
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Ohira Co.,Ltd.·1 device
Portable LED Light Source
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Machida Endoscope Co., Ltd.·1 device
RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
FDA Enforcement
Class II
·Ongoing·Eizo Corporation·June 17, 2020
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
FDA Enforcement
Class II
·Terminated·Eizo Corporation·July 22, 2015
RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
FDA Enforcement
Class II
·Ongoing·Eizo Corporation·June 17, 2020
Goodman Co., Ltd. Goodman Research Center
Manufacturer
🇯🇵 Japan
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
FDA Enforcement
Class II
·Terminated·Eizo Corporation·July 22, 2015
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
FDA Enforcement
Class II
·Terminated·Eizo Corporation·July 22, 2015
HAEMOSTASIS VALVES
Device
EU MDR
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Eu Md Class 2a
·Goodman Co. Ltd.·On the market·8 countries
Slit Lamp SL-203
Device
EU MDR
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Eu Md Class 1
·Ohira Co.,Ltd.·On the market·32 countries
Eye-Tracking Perimeter FIELDNavigator
Device
EU MDR
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Eu Md Class 1
·FINDEX Inc.·On the market·30 countries
CP-500
Device
EU MDD
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Eu Md Class 1
·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market
BR-7
Device
EU MDD
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Eu Md Class 1
·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market