BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM

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

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306813320·Tissue Forceps, 1x2, Smooth, 45.5 cm

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450113912·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0600070·Tray Insert, 1.5" Blank

    RADIONICS LUMBOPERITONEAL SHUNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO ARTOSCAN M

    FDA 510(k)
    FDA Class 2 ·Radiology

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    S5 CONTROL PANEL

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012

    BD NEEDLE 27X1/2 LL ECLIPSE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·September 3, 2024

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 19, 2013

    VENTAK PRIZM

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2008

    BD NEEDLE 27X1/2 LL ECLIPSE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·September 26, 2024

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013