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

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    VAAKA BABY SCALE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Integra DP Valve System

    FDA UDI
    INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780033493·Integra DP Valve System is an implantable devic...

    INOMAX DS (DELIVERY SYSTEM), MODEL 10003

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FM-02 BONE GRAFT SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTEGRA DP PEDIATRIC VALVE SYSTEM

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code JXG·January 31, 2017

    IMP CBL DIA2 SS CABLE SLEEVE

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 18, 2016

    IMP CBL DIA2 SS CABLE SLEEVE

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 18, 2016

    IMP CBL DIA2 SS &CABLE SLEEV

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 30, 2016

    IMP CBL DIA2 SS & CABLE SLEEVE

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDQ·July 20, 2016

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 8, 2014

    OCTRODE TRIAL LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 9, 2015

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017