BEUDAMED
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    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses

    FDA Enforcement
    Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

    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