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

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    KAM SUCKER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Traverse

    FDA UDI
    Nuvasive, Inc.·00887517154446·Traverse Plate, 65mm 2-Bolt

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator

    SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE

    FDA 510(k)
    FDA Class 2 ·Dental

    M2A-MAGNUM PF CUP 48ODX42ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014

    SAFE-T-CENTESIS TRAY, 6FR X 16 CM

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code GCB·April 5, 2010

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US·Product code KOG·October 9, 2012

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024