BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    PROPOSED CONTROLS FOR DOSIMETRIC RELEASE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    10PW - Hawaiian Telecom

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588120683·10PW - Hawaiian Telecom

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848120680·Self-Drilling Screw - Ø1.9 mm x 3 mm

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M384812068CP1·Self-Drilling Screw - Ø1.9 mm x 3 mm

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M384812068US0·Self-Drilling Screw - Ø1.9 mm x 3 mm

    EZout

    FDA UDI
    STRYKER CORPORATION·07613327294422·Blade Pack, 68mm

    SYNTHES ZERO-P VARIABLE ANGLE (VA)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

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

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 8, 2013

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 7, 2013

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 7, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 31, 2012

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·June 2, 2015

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    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