6,612 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
FDA 510(k)
FDA Class 2
·Radiology
NIKON-ESSILOR CO., LTD.
Manufacturer
🇯🇵 Japan
ASHITAKA FACTORY OF TERUMO CORP.
FDA registration
ASHITAKA FACTORY OF TERUMO CORP.·20 products·🇯🇵 Japan
Tanita Corporation of Akita, Ltd
FDA registration
Tanita Corporation of Akita, Ltd·5 products·🇯🇵 Japan
KOFU FACTORY OF TERUMO CORP.
FDA registration
KOFU FACTORY OF TERUMO CORP.·6 products·🇯🇵 Japan
ME CENTER OF TERUMO CORP.
FDA registration
ME CENTER OF TERUMO CORP.·1 product·🇯🇵 Japan
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
ME Center (Nagaizumi) of Terumo Corp
FDA registration
ME Center (Nagaizumi) of Terumo Corp·1 product·🇯🇵 Japan
Asahi Lite Optical Co., Ltd.
Manufacturer
🇯🇵 Japan
Toray Industries, Inc.
Manufacturer
🇯🇵 Japan·2 Importers
Toray Medical Co., Ltd.
Manufacturer
🇯🇵 Japan·1 Importer
Tokuyama Dental Corporation
Manufacturer
🇯🇵 Japan·1 Importer
Kaigen Pharma Co., Ltd.
Manufacturer
🇯🇵 Japan
Matsunaga Manufactory Co.,ltd.
Manufacturer
🇯🇵 Japan
Sun Medical Co., Ltd.
Manufacturer
🇯🇵 Japan·41 Basic UDI-DIs·55 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
OPHTECS Corporation
Manufacturer
🇯🇵 Japan·8 Basic UDI-DIs·20 Devices·1 Importer
TSK Laboratory International Japan KK
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device
HOYA Technosurgical Corporation
Manufacturer
🇯🇵 Japan
CITIZEN SYSTEMS JAPAN CO., LTD.
Manufacturer
🇯🇵 Japan·1 Importer
TAUNS Laboratories, Inc.
Manufacturer
🇯🇵 Japan·13 Basic UDI-DIs·14 Devices