BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FIBERLUME

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

    CONTEXT FILTER

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCESSORIES

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·March 6, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    SPRINT

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·August 8, 2014

    ACIST

    FDA Adverse Event
    Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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