BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    THE CIRCULATOR BOOT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Innovasis Gibralt Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I.V. CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

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    FDA Adverse Event
    Malfunction ·UNK·Product code GDY·September 17, 2012

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    FDA Adverse Event
    *·Product code FCW·September 10, 2010

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2010

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025