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

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    BORES* DEPTH GAUGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848120690·Self-Drilling Screw - Ø1.9 mm x 4 mm

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M384812069CP1·Self-Drilling Screw - Ø1.9 mm x 4 mm

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M384812069US0·Self-Drilling Screw - Ø1.9 mm x 4 mm

    RSP GLENOID BASEPLATE POROUS COATED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    HOMECHOICE PRO

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

    EXCELLENCE SS+

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    C-ARM

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·August 17, 2010

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025