BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    Extremity All Suture System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACROSSPINE PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 7, 2024

    HOLDING SLEEVE 55MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·September 21, 2018

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    HUDSON HVT ET TUBE 7.0 MM

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code BTR·August 19, 2011

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 22, 2013

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025