BEUDAMED
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    CELTRA Press

    FDA 510(k)
    FDA Class 2 ·Dental

    XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    TBA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENDOTAK DSP

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 13, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·September 12, 2008

    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

    TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 9, 2024

    L3O0200 - NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·June 4, 2021

    L3O0200 - NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·June 4, 2021

    L3O0200 - NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·June 4, 2021

    L3O0200 - NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·June 4, 2021

    L3O0200 - NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·June 4, 2021

    L3O0200 - NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·June 4, 2021

    L3O0200 - NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·June 4, 2021

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 23, 2020

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 23, 2020

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·May 28, 2020

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 13, 2020

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 23, 2020