BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    Gem Flow Now (GEM2770-FN)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AIRSTRIP REMOTE PATIENT MONITORING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    FLOSEAL HEMOSTATIC MATRIX

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - HAYWARD·Product code LMF·September 2, 2011

    MYNXGRIP (5F) VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Malfunction ·ACCESSCLOSURE, INC.·Product code MGB·November 6, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·February 12, 2018

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·March 24, 2017

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·March 29, 2017

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·March 6, 2018

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·April 9, 2018

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

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