BEUDAMED
    19 results · 33ms · Sources: EU EUDAMED, US FDA

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    CELL-DYN SAPPHIRE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    CELL-DYN DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

    CELL-DYN RUBY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425598724·LACERATION TRAY

    DBEST HCG 2 IU/ML TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIO-LOGIC ABAER CUB

    FDA 510(k)
    FDA Class 2 ·Neurology

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·March 11, 2017

    RD SET DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·February 17, 2017

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code DXY·April 10, 2013

    CONSULTA

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·April 12, 2011

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·May 23, 2008

    RAINBOW RC-4

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

    LNCS TC-I SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·August 31, 2015

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    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