BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS

    FDA 510(k)
    FDA Class 2 ·Dental

    MAGELLAN VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INF SET CLEO 24" 6MM

    FDA Adverse Event
    Malfunction ·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·January 12, 2026

    AMI

    FDA Adverse Event
    Other ·AIRWAY MANAGEMENT INC.·Product code LRK·July 10, 2013

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA·Product code NIM·December 3, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 3, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·September 16, 2014

    PUMP IN STYLE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·April 19, 2011

    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