BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    EPI-K

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MEDRAD STELLANT CT INJECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THERMAGE THERMACOOL II SYSTEM

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

    ACL TOP

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005

    ACL TOP

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005

    ACL ADVANCE

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005

    SELUTE PICOTIP

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·April 9, 2013

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 25, 2011

    INSIGNIA ENTRA

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

    M2A 38MM MOD HD STD NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 29, 2018

    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