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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    STOCKERT CARDIAC PACING ELECTRODES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848120490·Rigid Burr Hole Cover - Ø1.9 mm - 6 hole - 18 mm

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M384812049US0·Rigid Burr Hole Cover - Ø1.9 mm - 6 hole - 18 mm

    exCellerator Cervical Collection Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Oclet TDS 1000

    FDA 510(k)
    FDA Unclassified ·Unknown

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 15, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·August 18, 2010

    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