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

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    EPI-LOCK T.M. PRIMADERM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY

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

    ARK TONGUE CLEANER

    FDA 510(k)
    FDA Class 1 ·Dental

    NONDEHP LS LF PLUMSET-OLCP D-CHAN

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·April 18, 2014

    HALO90 ABLATION CATHETER

    FDA Adverse Event
    Other ·BARRX MEDICAL, INC.·Product code GEI·October 15, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·December 14, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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