11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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HLX Holder for DSA-81
Device
EU MDR
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Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
PreXion Corporation
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device
JM Ortho Corporation
Manufacturer
🇯🇵 Japan
J. MORITA TOKYO MFG. CORP.
Manufacturer
🇯🇵 Japan
ODONTOLOGY DEVICES - OTHER
Device
EU MDR
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Eu Md Class 2b
·PreXion Corporation·No longer on the market
PreXion3D Explorer PRO
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·PreXion Corporation·1 device
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
EVIS EXERA III Bronchovideoscope
FDA Enforcement
Class II
·Terminated·Aizu Olympus Co., Ltd.·August 31, 2022
The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. FLUOROspeed may be used for emergency treatment on an outpatient basis, as well as for bedside examinations.
FDA Enforcement
Class II
·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·November 13, 2024
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Enforcement
Class II
·Completed·Beckman Coulter Mishima K.K.·June 11, 2025