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

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    PINNACLE CONSTRAINED ACETABULAR LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LASER 3 SPSC300

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 9, 2013

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code KRD·February 24, 2011

    DISCOVERY II DR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

    3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018