BEUDAMED
    4 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    FDA Enforcement
    Class II ·Terminated·Z-Medica, LLC·June 28, 2017

    QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    FDA Enforcement
    Class II ·Terminated·Z-Medica, LLC·March 14, 2018

    QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

    FDA Enforcement
    Class II ·Terminated·Z-Medica, LLC·November 17, 2021