BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NAV PAK Needle, NIM NAV PAK Needle

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

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

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·February 28, 2013

    OPEN PIVOT MECHANICAL HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC ATS , INC.·Product code LWQ·February 1, 2011

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 16, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

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