19 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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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
PreXion Corporation
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device
JM Ortho Corporation
Manufacturer
🇯🇵 Japan
J. MORITA TOKYO MFG. CORP.
Manufacturer
🇯🇵 Japan
CL AIA-PACK SARS-CoV-2-Ab CONTROL SET
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Tosoh Corporation·1 device
ODONTOLOGY DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 2b
·PreXion Corporation·No longer on the market
2107788CE15
Certificate
MDD Annex II Section 4·ASAHI INTECC CO., LTD.·DEKRA Certification B.V.·1 Basic UDI-DI
PreXion3D Explorer PRO
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·PreXion Corporation·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