BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    CASSETTE SYSTEM FOR SITE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ZILVER 518 BILIARY STENT

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

    HumaPen Luxura

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·February 4, 2013

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLELLULOSE) MEMBRANE

    FDA Adverse Event
    GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·November 29, 2010

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2014

    ZILVER 518 SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 26, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

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