BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP

    FDA 510(k)
    FDA Class 2 ·Radiology

    PreXion Corporation

    Manufacturer
    🇯🇵 Japan·1 Basic UDI-DI·1 Device

    JM Ortho Corporation

    Manufacturer
    🇯🇵 Japan

    J. MORITA TOKYO MFG. CORP.

    Manufacturer
    🇯🇵 Japan

    ODONTOLOGY DEVICES - OTHER

    Device
    EU MDR · Eu Md Class 2b ·PreXion Corporation·No longer on the market

    Mesh Cap

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·OMRON Healthcare Co., Ltd.·1 device

    Mesh Cap U22

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·OMRON Healthcare Co., 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

    PENTAX Medical Single Use, Sterile Distal End Cap with Elevator

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·HOYA Corporation ·1 device

    PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A65

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·HOYA Corporation ·1 device

    PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·HOYA Corporation ·1 device

    PreXion3D Explorer PRO

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·PreXion Corporation·1 device