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

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    ALKALINE PHOSPHATASE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SpineWand

    FDA UDI
    MORGAN STEER ORTHOPAEDICS LIMITED·05060696460019·Perc DLG Convenience Pack inc 17 gauge 8” Crawf...

    Coblation

    FDA UDI
    Smith & Nephew, Inc.·00817470004489·PERC DLG

    TRIALTIS

    FDA UDI
    DEPUY SPINE, LLC·10705034596129·Double Side by Side Connector, 11mm

    ROUND FILTERS W/INDICATOR

    FDA Adverse Event
    Malfunction ·SPS MEDICAL·Product code FRG·February 28, 2014

    SMITH & NEPHEW INSTRUMENT TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRANSPORT INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FULL-SIZE LID W/RETENTION PLATE SILVER

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code FRG·March 10, 2016

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 2, 2014

    BALLOON KYPHOPLASTY

    FDA Adverse Event
    Injury ·MDT KYPHON SUNNYVALE MFG·Product code HRX·October 16, 2012

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025