BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ULTRACLONE ECL-01-500 CELL LINE

    FDA 510(k)
    FDA Class 1 ·Hematology

    PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AEQUALIS FX2

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PFC SIGMA CRVD INSERT SZ3 8MM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JWH·April 30, 2019

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 30, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 23, 2012

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·September 13, 2010

    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