BEUDAMED
    467 results · 28ms · Sources: EU EUDAMED, US FDA

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    Disposable Dual Bore PFC Cannula

    FDA UDI
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872014746·

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00887709098268·ENFit™ Lopez Valve™ Non-Sterile

    Eftiar Dual Bore Cannula.(23 gauge / 0.6 mm)

    FDA UDI
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872014753·

    EFD FIELD Detector

    FDA UDI
    IBA Dosimetry GmbH·EIBA999602BT0·EFD 3G-pSi Fielddetector, BNC

    EFD FIELD Detector

    FDA UDI
    IBA Dosimetry GmbH·EIBA9996020·EFD 3G-pSi Fielddetector

    EFD FIELD Detector

    FDA UDI
    IBA Dosimetry GmbH·EIBA999602T0·EFD 3G-pSi Fielddetector, TNC

    ENTERAL FEEDING DEVICE (EFD)

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code KNT·July 31, 2023

    INJECTION GOLD PROBE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC MIAMI·Product code KNS·March 10, 2006

    CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code GBX·October 12, 2022

    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NIK·October 4, 2017

    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·November 15, 2017

    LEVEL 1

    FDA Adverse Event
    Malfunction ·Product code LGZ·April 6, 2021

    LEVEL 1

    FDA Adverse Event
    Malfunction ·Product code LGZ·May 19, 2021

    LEVEL 1

    FDA Adverse Event
    Malfunction ·Product code LGZ·May 19, 2021

    LEVEL 1

    FDA Adverse Event
    Malfunction ·Product code LGZ·April 19, 2021

    LEVEL 1

    FDA Adverse Event
    Malfunction ·Product code LGZ·May 19, 2021

    LEVEL 1

    FDA Adverse Event
    Malfunction ·Product code LGZ·May 19, 2021

    LEVEL 1

    FDA Adverse Event
    Malfunction ·Product code LGZ·August 24, 2021

    3M ESPE PENTAMIX 3 AUTOMATIC MIXING UNIT

    FDA Adverse Event
    3M DEUTSCHLAND GMBH·Product code EFD·October 31, 2014

    3M ESPE PENTAMIX LITE AUTOMATIC MIXING UNIT

    FDA Adverse Event
    3M DEUTSCHLAND GMBH·Product code EFD·November 11, 2014