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

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    ARROW-JOHANS ECG ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRIMED OSTEOTOMY PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·June 2, 2014

    2214133-2012-00343

    FDA Adverse Event
    Malfunction ·PERSONAL PRODUCTS CO.·November 22, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 24, 2010

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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