BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    ORTHO CMV-M ANTIBODY ELISA TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Eclipse®

    FDA UDI
    Dentsply International Inc.·D0019050770·Light Reddish Pink

    ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH INC.·Product code GTZ·July 18, 2018

    SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM

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

    1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 28, 2024

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 22, 2010

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 1, 2014

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 5, 2025

    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

    FDA Enforcement
    Class II ·Ongoing·Acclarent, Inc.·December 29, 2021

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025