BEUDAMED
    10 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 31, 2018

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.

    FDA Enforcement
    Class II ·Completed·CTL Medical Corporation·July 15, 2020

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.

    FDA Enforcement
    Class II ·Completed·CTL Medical Corporation·July 15, 2020

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.

    FDA Enforcement
    Class II ·Completed·CTL Medical Corporation·July 15, 2020

    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.

    FDA Enforcement
    Class II ·Completed·CTL Medical Corporation·July 15, 2020

    CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050

    FDA Enforcement
    Class II ·Terminated·CTL Medical Corporation·March 27, 2019

    CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050

    FDA Enforcement
    Class II ·Terminated·CTL Medical Corporation·March 27, 2019

    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021