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

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    PherDal® At-Home Insemination Kit

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

    BD BBL™ Sensi-Disc™ Imipenem 10 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902316450·BD BBL™ Sensi-Disc™ Imipenem 10 µg

    Regatta Lateral System

    FDA UDI
    Seaspine Orthopedics Corporation·10889981159245·Lateral Implant, 23mm x 16mm x 45mm, 15 Deg

    EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    3F AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC 3F THERAPEUTICS, INC.·Product code LWR·April 25, 2017

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·November 14, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    RECAP SHELL COCR PC 50/44MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·July 17, 2013

    BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    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