BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Stainless Steel Wire

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746047503·WIRE SS LOWER 017 X 025 FORM II 10/PK

    FIDIS CELIAC

    FDA 510(k)
    FDA Class 2 ·Immunology

    DISPOSABLE TRACH SWIVEL CONNECTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    AFFIRM INFLATABLE BONE TAMP PACK, ULTRA, 15U

    FDA Adverse Event
    Malfunction ·GLOBUS MEDICAL, INC.·Product code NDN·April 7, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·October 5, 2010

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 30, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40

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