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

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    COBURN I/A SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209119783·KIT, MCI WALK - TRAINER - CUSTOM

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·September 3, 2019

    VAPORMAX II

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

    ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 6, 2014

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·November 30, 2012

    PRESTO BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·AGAMATRIX, INC·Product code NBW·September 28, 2010

    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