BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGAMAX 5 MM

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY LLC·Product code FZP·February 21, 2013

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVE, INC.·Product code LWR·February 1, 2011

    SYMBIQ 3.13 SINGLE C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 24, 2014

    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