2,680 results · 18ms · Sources: EU EUDAMED, US FDA

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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