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

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    Filters Regulation: Us FDA ×

    EPIC CANNULA

    FDA 510(k)
    FDA Class 1 ·Dental

    ROUND FILTERS W/INDICATOR

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

    LIFEGLOBAL PROTEIN SUPPLEMENT

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

    InCore TMT System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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 CORPORATION·Product code FRN·January 2, 2014

    UNKNOWN SROM ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code KWA·October 16, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·May 20, 2015

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021