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

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    Curasite

    FDA 510(k)
    FDA Unclassified ·Unknown

    PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA

    FDA 510(k)
    FDA Class 2 ·Hematology

    WEBSTER DUO-DECAPOLAR CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·SOFAMOR DANEK EUROPE·Product code KWP·May 19, 1999

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

    BLAKE DRAIN

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON·Product code FFA·July 2, 1992

    UNKNOWN NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·July 11, 2011

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·May 29, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 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