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

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    CARDIOSTATION-100 (CS-100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    URANUS, COMFORTOUCH LASER SYSTEM

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

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 15, 2022

    RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013

    ST JOSEPHS PHOENIX, AZ 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code DWF·July 31, 2009

    RU NOVOSIBRIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013

    RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DWF·October 16, 2013

    CP87170 DE MUENCHEN

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011

    DISOPA SOLUTION

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON·Product code LRJ·May 9, 2008

    CP87641 GB SOUTHAMPTON

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·March 22, 2010

    DREAMSTATION AUTO CPAP W/HUM/CELL, DOM

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·September 20, 2021

    D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013