BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015

    FDA 510(k)
    FDA Class 2 ·Dental

    DIGITALDIAGNOST 4.1 HIGH PERFORMANCE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS DMC GMBH·Product code MQB·August 9, 2024

    MODIFICATION TO VNUS CLOSURE SYSTEM

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

    HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

    FINELINE II

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

    LAUNCHER 6F (JR4.0)

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code DQY·March 15, 2011

    INSIGNIA PLUS

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

    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