BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    POLY-CHEM CREATININE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NB3D BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRAUMACEM CEMENT KIT

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NDN·June 11, 2013

    E SERIES DEFIBRILALTOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 24, 2014

    ICEMAN THERAPY UNIT

    FDA Adverse Event
    Injury ·DJ ORTHOPEDICS DE MEXICO·Product code ILO·July 11, 2011

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014