14 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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DKK DAI-ICHI SHOMEI CO, LTD
FDA registration
DKK DAI-ICHI SHOMEI CO, LTD·5 products·🇯🇵 Japan
N-Histofine DAB-２V
Device
EU IVDR
·
Eu Ivd Class A
·Nichirei Biosciences Inc.·On the market·10 countries
N-Histofine DAB-２V
Device
EU IVDR
·
Eu Ivd Class A
·Nichirei Biosciences Inc.·On the market·10 countries
N-Histofine DAB-２V
Device
EU IVDR
·
Eu Ivd Class A
·Nichirei Biosciences Inc.·On the market·10 countries
N-Histofine DAB-3S KIT
Device
EU IVDR
·
Eu Ivd Class A
·Nichirei Biosciences Inc.·On the market·10 countries
N-Histofine DAB-3S KIT
Device
EU IVDR
·
Eu Ivd Class A
·Nichirei Biosciences Inc.·On the market·10 countries
N-Histofine DAB-3S KIT
Device
EU IVDR
·
Eu Ivd Class A
·Nichirei Biosciences Inc.·On the market·10 countries
DBB-06 Hemodialysis Delivery System
FDA Enforcement
Class II
·Ongoing·Nikkiso Ltd - Shizuoka Plant·January 12, 2022
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
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