BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    KSEA ENDOSCOPES FOR DENTAL PROCEDURES

    FDA 510(k)
    FDA Class 1 ·Dental

    Bioliner

    FDA 510(k)
    FDA Class 2 ·Dental

    ANGIOSCOPE FOR PULMONARY ARTERY USE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·June 16, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·February 28, 2013

    SILVERHAWK® SXL PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code MCW·February 9, 2011

    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