BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    INSUFFLATOR FILTER TUBING SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODEL 3D3 OSMOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FLOWGUN ELECTROCAUTERY PROBE HANDLE

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

    UNK

    FDA Adverse Event
    Injury ·Product code HWC·February 1, 2013

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·July 21, 2014

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·January 4, 2011

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·September 8, 2025

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020