BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    MAGNA-ROM 21 KNEE SYSTEEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PowerFlow Implantable Apheresis IV Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SICKLE-CELL F TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACIST

    FDA Adverse Event
    Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 6, 2013

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014

    DA+ C SERIES DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code DXY·February 15, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40

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