17 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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Intuitive Surgical G.K.
FDA registration
Intuitive Surgical G.K.·16 products·🇯🇵 Japan
Zimmer Biomet G.K.
FDA registration
Zimmer Biomet G.K.·46 products·🇯🇵 Japan
Arthrex Japan G.K. (Shinjuku)
FDA registration
Arthrex Japan G.K. (Shinjuku)·31 products·🇯🇵 Japan
Medline Logistics Japan G.K.
FDA registration
Medline Logistics Japan G.K.·1 product·🇯🇵 Japan
DKK DAI-ICHI SHOMEI CO, LTD
FDA registration
DKK DAI-ICHI SHOMEI CO, LTD·5 products·🇯🇵 Japan
HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS
Device
EU MDR
·
Eu Md Class 2a
·TSK Laboratory International Japan KK·On the market·1 country
Bayonet Forceps GK2 Long31-5163
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Charmant Inc.·1 device
Bayonet Forceps GK2 Medium 31-5162
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Charmant Inc.·1 device
Bayonet Forceps GK Long 31-5154
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Charmant Inc.·1 device
Bayonet Forceps GK Medium 31-5153
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Charmant 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