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

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    APEX MODULAR HA HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMS PULMONARY FUNCTION TESTING FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RENAX A.V. FISTULA NEEDLE SETS

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

    CP840442 DE LEIPZIG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 12, 2010

    CP025369 DE LEIPZIG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·August 3, 2011

    CP85315 IT MODENA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·January 14, 2013

    CP84050 FR LA REUNION

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·May 17, 2012

    CP84042 DE LEIPZIG %

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·April 20, 2011

    D905 DIDECO EOS SINGLE HVR

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·September 25, 2013

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·April 9, 2013

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Malfunction ·C. R. BARD, INC. (BASD)·Product code KNT·February 24, 2011

    VITALITY AVT

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    M2A 38MM MOD HD STD NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 29, 2018

    D905 EOS OXYGENATOR (PHISIO TREATED)

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·July 13, 2018

    D905 EOS PHISIO OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·August 8, 2017

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016