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

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    IMPLEX BIPOLAR HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970447·anteriors; shade D4; mould BIS

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044710001·Dowel Pin 17 mm

    EPC INSTICKS

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEWDEAL COMPRESSION PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 13, 2024

    ARCHITECT IPTH

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code CEW·February 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 31, 2014

    O.B. UNSPECIFIED

    FDA Adverse Event
    Injury ·MONTREAL SAN PRO·Product code HEB·January 20, 2011

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015