17 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Amplatz Left 1.0cm, Side Hole
Device
EU MDD
·
Eu Md Class 3
·ASAHI INTECC CO., LTD.·No longer on the market·30 countries
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
Device
EU IVDR
·
Eu Ivd Class A
·SYSMEX CORPORATION·On the market·32 countries
Add-On Buffer Unit
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi, Ltd.·On the market
LabSolutions LC CL Add PDA
Device
EU IVDD
·
Eu Ivd General
·Shimadzu Corporation·On the market
PreXion Corporation
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device
JM Ortho Corporation
Manufacturer
🇯🇵 Japan
J. MORITA TOKYO MFG. CORP.
Manufacturer
🇯🇵 Japan
HISCL DISPOSABLE TIP
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·SYSMEX CORPORATION·1 device
ODONTOLOGY DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 2b
·PreXion Corporation·No longer on the market
Add-On Buffer Unit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Hitachi, Ltd.·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
PreXion3D Explorer PRO
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·PreXion Corporation·1 device