17 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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MUX-10
Device
EU MDD
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Eu Md Class 2b
·Shimadzu Corporation·On the market·9 countries
MUX-10
Device
EU MDD
·
Eu Md Class 2b
·Shimadzu Corporation·On the market·9 countries
MUX-10
Device
EU MDD
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Eu Md Class 2b
·Shimadzu Corporation·On the market·9 countries
AUX Connection Cable
Device
EU MDR
·
Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
AUX Connection Cable
Device
EU MDR
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Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
AUX Connection Cable
Device
EU MDR
·
Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
AUX Connection Cable
Device
EU MDR
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Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
AUX Unit Mounting Bracket
Device
EU MDR
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Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
AUX Connection Cable LEM
Device
EU MDR
·
Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
AUX Connection Cable LEM
Device
EU MDR
·
Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
AUX Connection Cable LEM
Device
EU MDR
·
Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
AUX Connection Cable LEM
Device
EU MDR
·
Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
FDA 510(k)
FDA Class 2
·Dental
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016
Mobile X-ray System MUX-10
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Shimadzu Corporation·1 device
Mobile X-ray System MUX-10
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Shimadzu Corporation·1 device
Mobile X-ray System MUX-10
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Shimadzu Corporation·1 device