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

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    PHOENIX

    FDA 510(k)
    FDA Class 2 ·Radiology

    TLC Uni Knee Meniscal Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215077365·

    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA

    FDA 510(k)
    FDA Class 2 ·Immunology

    THERMO SCIENTIFIC MAS OMNI-CARDIO

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MPS2 CONSOLE

    FDA Adverse Event
    Malfunction ·QUEST MEDICAL, INC.·Product code DTR·February 7, 2025

    QUATERA 700 BIMANUAL I/A HANDPIECE SET

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·August 15, 2011

    LATERAL CLAW CONNECTOR 45/55MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·July 9, 2013

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023