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

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    CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PERMITE

    FDA UDI
    SDI LIMITED·DO3640502022·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110627·LOCATOR R-Tx Abutment for Wide Platform (WP) In...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481121111·LOCATOR F-Tx Abutment For Wide Platform (WP) In...

    SILVERVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948003161·SILVERVENT 1 IC + 1 ICU, SIZE 2

    OptiLIF Endo, Direct Visualization System

    FDA UDI
    SPINEOLOGY INC.·M7401050202·60°Angled Ring Curette

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481128790·LOCATOR R-Tx Abutment, Wide Platform (WP) Tri-c...

    CORTEK LAPAROSCOPES

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

    OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES

    FDA 510(k)
    FDA Class 2 ·Neurology

    RD SET GE - 12

    FDA Adverse Event
    Malfunction ·Product code DQA·August 13, 2021

    GREENLIGHT HPS LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 5, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 1, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·May 23, 2008

    Laryngectomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050200 size 8 and item number 1050202 size 10.

    FDA Recall
    Terminated ·Premier Dental Products Co·Product code JOH·August 5, 2004

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015