BEUDAMED
    12 results · 37ms · Sources: EU EUDAMED, US FDA

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    Hee HR Mini

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO COLLAWOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    NOVATION CROWN CUP GXL LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO FLEX METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 27, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 27, 2021

    MINI STICK 4.0 F X 10CM STIFF INTRODUCER

    FDA Adverse Event
    Malfunction ·MEDRON, LLC·Product code DYB·August 7, 2018

    ZOOM

    FDA Adverse Event
    Malfunction ·CPI PLANT - ST. PAUL·Product code KRG·July 20, 2011

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·June 14, 2013

    PLUM XLM PUMP

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·September 11, 2008

    Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020