BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377069474·RELINE C Screw, 4.0x22mm FA

    3M™ ESPE™

    FDA UDI
    3M COMPANY·30605861026810·3M™ ESPE™ Pedodontic Anterior Strip Crown Form,...

    36PW Genesee & Wyoming Fleet - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588149226·36PW Genesee & Wyoming Fleet - Poly White

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837015084·

    Accu-Chek Softclix Blood Lancing System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MRI LINE MARKER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTAMET MTL INS NEUT 36MM 56OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 1, 2010

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 14, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·July 3, 2014

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015