BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    TAMPONADE BALLOON CUFF

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

    WATCH-PAT200U (WP200U)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·May 27, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 15, 2012

    HYDRELLE

    FDA Adverse Event
    Other ·ANIKA THERAPEUTICS, INC.·Product code LMH·September 7, 2010

    UNKNOWN

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 20, 2025

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018