BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    ATS GRAM STAIN CONTROL SLIDE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    AUTOMATED ENDOSCOPE LEAK TESTER

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

    KSEA SCB ACC CONTROL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FT BIPOLAR RESECTION CORD STORZ

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·May 1, 2014

    U BY KOTEX CLICK TAMPONS

    FDA Adverse Event
    Malfunction ·QINGDAO P&B CO. LTD·Product code HEB·January 10, 2011

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC.·Product code NDN·August 26, 2010

    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 18, 2012