BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    CORTISOL ENHANCED LUMINESCENCE ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SMARTBURS

    FDA 510(k)
    FDA Class 1 ·Dental

    Reliance Lumber IBF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017

    MONOPLUS C VIOLET 0 (3,5) 25M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code NEW·May 28, 2014

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code MND·October 25, 2010

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CFR·December 20, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

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

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025