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

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    LABORATORY DATA MGMT SYSTEM SDMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PROFUSION BONE VOID FILLER KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIODE LASER FOR HIAR REMOVAL

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

    UNIVERSAL OCILLATING SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A·Product code GEY·March 6, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 9, 2012

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·September 8, 2010

    SPECTRAFLEX

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·October 26, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015