BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    GEM-STIM COMBO STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    TORFLEX TRANSSEPTAL GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CONSTELLATION

    FDA Adverse Event
    Malfunction ·ALCON·Product code HQC·May 6, 2011

    BD SCHAEDLER AGAR WITH VITAMIN K1 AND 5% SHEEP BLOOD, PLATE, 90 MM X 120

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSG·July 26, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 21, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    BRAIN LAB V. 3.0.2 TREATMENT PLANNING SOFTWARE

    FDA Adverse Event
    Death ·BRAINLAB, INC.·Product code MUJ·June 7, 2011

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.

    FDA Recall
    Terminated ·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DYB·September 23, 2013

    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.

    FDA Enforcement
    Class I ·Terminated·Baylis Medical Corp *·November 13, 2013