8 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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Multi-attachment for OTV-03
Device
EU MDR
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Eu Md Class 1
·Fukuda Denshi Co., Ltd.·On the market·32 countries
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV
FDA 510(k)
FDA Class 2
·Ophthalmic
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 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