BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    HUMAN SERUM ALBUMIN (HSA)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    JO H2O Jelly Original Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FIRST MEDIC MODE 610

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

    SKIN-PREP WIPES BOX

    FDA Adverse Event
    Death ·SMITH & NEPHEW WOUND MANAGEMENT·Product code NEC·February 28, 2013

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 6, 2014

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 19, 2016

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024