BEUDAMED
    8 results · 24ms · Sources: EU EUDAMED, US FDA

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    Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    All Poly Monotrial UC

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215081331·

    MACROLYTE DISPERSIVE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AXSOS (TM) LOCKING PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 27, 2011

    GYNECARE TVT OBTURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 20, 2013

    BIOCOR STENTED PORCINE HEART VALVE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·September 26, 2008

    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