BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    D100 KIDS; D101 KIDS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KIDS OXYGENATOR D101

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025

    VASCUPUNCTURE PICC GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TIBIAL PLATE FB SZ 3 RT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·March 20, 2024

    LUMAX 300 DR-T

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH & CO.·Product code MRM·November 14, 2008

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 1, 2011

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTP·July 12, 2013

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016