BEUDAMED
    3 results · 59ms · Sources: EU EUDAMED, US FDA

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    The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

    FDA Enforcement
    Class II ·Ongoing·Dutch Ophthalmic USA, Inc.·August 18, 2021

    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06

    FDA Enforcement
    Class II ·Terminated·Dutch Ophthalmic USA, Inc.·July 28, 2021

    Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

    FDA Enforcement
    Class II ·Ongoing·Dutch Ophthalmic USA, Inc.·July 28, 2021