BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    ActiveCare TD-4121 Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981140250·Offset hook, 5.5 x 11mm, right

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100844·MCNEILL GLOBAL FIXATION RING SMALL

    ECHOSTAR SPICA 1.5T MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LITECURE THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·February 14, 2012

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 30, 2015

    BD MICRO-FINE¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·April 24, 2018

    BD MICRO-FINE¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·August 31, 2018

    BD MICRO-FINE¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 22, 2018

    GOLVO

    FDA Adverse Event
    Malfunction ·LIKO AB·Product code FSA·May 31, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 23, 2011

    PLUM A+ DRIVER ED 2

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014

    BD PLASTIPACK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·May 10, 2018

    7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·July 26, 2017