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

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    EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM

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

    IMPROVED TRY-IN GEL

    FDA 510(k)
    FDA Class 2 ·Dental

    PF 5050 PRESSURE UNIT, MODEL PF 5050

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·April 26, 2018

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 16, 2013

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·June 20, 2008

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·April 5, 2011

    HEARTMATE MOBILE POWER UNIT, NA

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 2, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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