BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTERPIECE™ Plate Fixation System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902569227·PLATE 853-410 10MM GRFT PLT

    Speedlock

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657021920·Biopsy Spoon, with Spike, 5mm, Double Action In...

    3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COULTER® LH 780 HEMATOLOGY ANALYZER

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014

    MAINFRAME 8252001 NIM-RESPONSE 2.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·November 30, 2012

    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024