2,680 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
FDA Enforcement
Class II
·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023
MASAHIRO MARUYAMA Inc.
Manufacturer
🇯🇵 Japan
NIDEK.CO.Ltd.,
Manufacturer
🇯🇵 Japan·27 Basic UDI-DIs·61 Devices·10 Importers
NIKON-ESSILOR CO., LTD.
Manufacturer
🇯🇵 Japan
OKAMOTO INDUSTRIES, INC. Ibaraki Plant
Manufacturer
🇯🇵 Japan·2 Importers
Menicon Co., Ltd.
Manufacturer
🇯🇵 Japan·4 Importers
NABTESCO CORPORATION ACCESSIBILITY INNOVATIONS COMPANY
Manufacturer
🇯🇵 Japan·1 Importer
EYEVAN Inc.
Manufacturer
🇯🇵 Japan·30 Basic UDI-DIs·1910 Devices·1 Importer
MATSUDA EYEWEAR JAPAN LLC
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·575 Devices·1 Importer
Sagami Rubber Industries Co., Ltd.
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·26 Devices
GE Healthcare Japan Corporation
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·8 Devices
DZ-C100
Device
EU MDR
·
Eu Md Class 1
·Yamagata Casio CO., LTD.·On the market·6 countries
α1-Microglobulin Calibrator Set
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
small dense LDL-Control Set
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
small dense LDL-Calibrator
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
α1-Microglobulin
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
α1-Microglobulin
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
α1-Microglobulin
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
small dense LDL Seiken
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
small dense LDL Seiken
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries