BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    INFUSION PORT BALLOON THERMODILUTION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LONESTAR

    FDA UDI
    Orthofix US LLC·18257200090440·DIA 4.0MM X 18MM RESCUE BONE SCREW - SELF TAPPING

    EBI LACTOSORB GRAFT CONTAINMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Dental Barrier and Sleeves

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

    DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·May 27, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·November 7, 2012

    FALOPE-RING BAND TWO-RING APPLICATOR, 8 MM

    FDA Adverse Event
    Other ·GYRUS MEDICAL INC.·Product code KNH·September 9, 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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024