BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Arthrex SoftStitch

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

    REPROCESSED PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·April 5, 2023

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·October 6, 2008

    PACS SERVER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code LLZ·June 24, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020