BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    IMMULITE 2000 3RD GENERATION PSA

    FDA 510(k)
    FDA Class 2 ·Immunology

    TECNOL SPLASHGUARD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GAUZE BANDAGE ROLL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LEVEL 1

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LGZ·December 16, 2020

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFE CORPORATION·Product code MVK·June 11, 2014

    75MM SELECTABLE NEW TLC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 22, 2013

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·January 31, 2011

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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