BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    BIPOLAR FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INREACH SYSTEM, MODEL AAS00161-02

    FDA 510(k)
    FDA Class 2 ·Radiology

    Shoulder Innovations Total Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 10, 2014

    5 FR DL POWERPICC, NURSING FULL

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·October 12, 2012

    SIGMA 300 SR

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code DXY·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

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021