14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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E-TYPE CONTRA ANGLE NAC-E
FDA 510(k)
FDA Class 1
·Dental
Surgical Angle Handpiece, Surgical Straight Handpiece
FDA 510(k)
FDA Class 2
·Dental
E-TYPE SPEED REDUCER CONTRA ANGLE
FDA 510(k)
FDA Class 2
·Dental
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
FDA 510(k)
FDA Class 1
·Dental
ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16, 0.016", 135cm, 45 angle
Device
EU MDD
·
Eu Md Class 2a
·ASAHI INTECC CO., LTD.·On the market·30 countries
ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16, 0.016", 180cm, Double angle
Device
EU MDD
·
Eu Md Class 2a
·ASAHI INTECC CO., LTD.·On the market·30 countries
ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16. 0.016", 180cm, 45 angle
Device
EU MDD
·
Eu Md Class 2a
·ASAHI INTECC CO., LTD.·On the market·30 countries
ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16, 0.016", 165cm, Double angle
Device
EU MDD
·
Eu Md Class 2a
·ASAHI INTECC CO., LTD.·On the market·30 countries
ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16, 0.016", 165cm, 45 angle
Device
EU MDD
·
Eu Md Class 2a
·ASAHI INTECC CO., LTD.·On the market·30 countries
ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16, 0.016", 135cm, Double angle
Device
EU MDD
·
Eu Md Class 2a
·ASAHI INTECC CO., LTD.·On the market·30 countries
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·April 6, 2016
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFSST2323TV, LFSLFSST2323, LDFSLFSLED7TV5, LDFSLFSLED7TV55, LFSLED55, LFSLFSST23, LFSST2923TV, LFSST29TV, LFSST29, LFSST19WC, LFSST2923, LFSLFSST-1, LFSST292323, LFSST1919WC, LFS ST2319WC
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023
LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·October 11, 2023