BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    SAS SPICER-EDWARDS L COMPLEX

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Zuma™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981060558·Trial, 32mm x 25mm x 12mm, 12 Deg

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221118233·3M™ Victory Series™ Second Molar Bands, 955-228...

    FORERUNNER AED, US ENGLISH, REFURB

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST RETURNS)·Product code MKJ·May 31, 2012

    MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FEMORAL HEMI-HIP PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·February 11, 2013

    CURRENT PLUS DR, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011

    OSCILLATING SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code GFA·July 24, 2014

    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 31, 2016

    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