15 results
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15ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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Nakanishi Inc.
Manufacturer
🇯🇵 Japan·1 Importer
DKK DAI-ICHI SHOMEI CO, LTD
FDA registration
DKK DAI-ICHI SHOMEI CO, LTD·5 products·🇯🇵 Japan
TSK Laboratory International Japan KK
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device
SPOTCHEM D Electrolyte (Na, K, Cl)
Device
EU IVDD
·
Eu Ivd General
·ARKRAY Factory, Inc.·On the market
SPOTCHEM Electrolyte Control [Na, K, Cl]
Device
EU IVDD
·
Eu Ivd General
·ARKRAY Factory, Inc.·On the market
HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS
Device
EU MDR
·
Eu Md Class 2a
·TSK Laboratory International Japan KK·On the market·1 country
SPOTCHEM D Electrolyte (Na, K, Cl)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·ARKRAY Factory, Inc.·1 device
SPOTCHEM Electrolyte Control [Na, K, Cl]
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·ARKRAY Factory, Inc.·1 device
Cannula
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·TSK Laboratory International Japan KK·1 device
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