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

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    PRISMATHERM II, ASTOLINE

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYNTHES ORACLE PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 6, 2013

    MAXIMO DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·February 15, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 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