BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    DYNABITE UROLOGICAL FORCEPS

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    Barco

    FDA UDI
    Barco NV·05415334031883·MDFC-8232 3SW

    ECLIPSE

    FDA Adverse Event
    Malfunction ·BBRAUN·Product code MEB·September 15, 2011

    Revi System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VISION (WITH OFF-LINE REVIEW)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSURE FIX MRI

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·February 9, 2013

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·January 3, 2011

    MAXI MOVE

    FDA Adverse Event
    Injury ·ARJO MED AB LTD.·Product code FSA·July 2, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026