BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    ENROUTE® Transcarotid Neuroprotection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517630421·CoRoent Ant TLIF Ti, 13x10x40mm 12°

    Rx Knee Flexible Olive Reamer Size 14

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215149918·

    ARTHROSCOPY PUMP, MODEL A107

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPIDER SYSTEM KOLIBRI CEMENT NEEDLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROTEM SIGMA SYSTEM

    FDA Adverse Event
    Malfunction ·TEM INNOVATIONS GMBH·Product code JPA·November 17, 2023

    RAPIDTRANSIT MICROCATHETERS

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code KRA·November 7, 2008

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 15, 2011

    COULTER® AC T 5DIFF AL ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 16, 2013

    EasyPoint Needle, 25G x 5/8", REF: 82091

    FDA Enforcement
    Class II ·Ongoing·Retractable Technologies, Inc.·March 20, 2024

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FRN·February 1, 2024

    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

    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