BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    AMSURE NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    StrykeFlow

    FDA UDI
    STRYKER CORPORATION·07613327051797·Reusable Suction Irrigation Tip, Standard, Vent...

    CHILI VIDEO, CHILI VIDEOPRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM

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

    CARTRIDGE

    FDA Adverse Event
    Injury ·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015

    ACUITY

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·April 22, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 19, 2011

    HYDRATOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·July 3, 2008

    Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·May 15, 2013

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014