BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    SONOTIP II ULTRASOUND NEEDLE SYSTEM

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

    MIXJECT

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240962·MIXJECT™ 13mm w/27G Needle (Mixject Transfer De...

    Vial Adapter

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240511·Vial Adapter 13mm ML SIL - VF

    Vial Adapter

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240306·Vial Adapter 13mm ML SIL - VF

    Cordant

    FDA UDI
    Seaspine Orthopedics Corporation·10889981115180·29mm

    EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 25, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

    ACRYSERT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 22, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021