BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    'EXMOOR' T-TUBE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705725·GC Initial™ LF Opaqus Dentin ODA4, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710351·GC Initial™ LF Opaqus Dentin ODA4, 20g

    IFS BONE FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Katalyst Mark 1 Muscle Stimulation System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·December 12, 2012

    AVAULTA PLUS SYNTHETIC SUPPORT SYSTEM: ANTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code FTL·October 8, 2010

    SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE

    FDA Adverse Event
    Malfunction ·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015

    ABC HANDPIECE LAPAROSCOPIC

    FDA Adverse Event
    Malfunction ·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015