BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ROCHE ONLINE TDM PHENYTOIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COVAMESH

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

    CADD SOLIS PUMP KIT

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code MEA·May 30, 2022

    BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·March 31, 2021

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·November 7, 2008

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 15, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

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

    Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 25, 2026

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

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